Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Heart Failure

Cardiomyopathies

Cardiotoxicity

Breast Diseases

Skin Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Patients recieving anthracycline based chemotherapy who fall into the low and moderate risk category following HFA - ICOS cardiac risk assessment as per the European Society of Cardiology Guidelines.

These patients are monitored taking biobank bloods, bloods, ecg and cardiac echo as per the European Society of Cardiology guidelines whilst receiving chemotherapy.

Patients who recieving anthracycline who fall into the high and very high risk category following HFA - ICOS cardiac risk assessment as per the European Society of Cardiology Guidelines.

These patients are monitored taking biobank bloods, bloods, ecg and cardiac echo as per the European Society of Cardiology guidelines whilst receiving chemotherapy.

Patients who are recieving herceptin that fall into the low and moderate risk category following HFA-ICOS cardiac risk assessment as per the European Society of Cardiology Guidelines. These patients are monitored taking biobank bloods, bloods, ecg and cardiac echo as per the European Society of Cardiology Guidelines.

Patients who are recieving herceptin that fall into the high and very high risk category following HFA-ICOS cardiac risk assessment as per the European Society of Cardiology Guidelines. These patients are monitored taking biobank bloods, bloods, ecg and cardiac echo as per the European Society of Cardiology Guidelines.

Osama Soliman, MBBCh, PhD

Aoife Lowery, MBBCh, PhD

Osama Soliman, MBBCH, PHD

Aoife Lowery, MBBS, PhD

Osama Soliman, MB BCh,PhD

Aoife Lowery, MB BCh, PhD

Veronica McInerney, MD,PhD

William Wijns, MD, PhD

Michael Kerin, MD, PhD

Maccon Keane, MD,PhD

Silvie Blazkova, MB BCh

In Ireland, over 3,000 patients are diagnosed with breast cancer annually, and 1 in 9 Irish women will be diagnosed with breast cancer in their lifetime. There is evidence that female breast cancer survivors are more likely to die of cardiovascular disease than their age-matched counterparts.

This research is focused on evaluating pathways for identifying, managing, and overcoming side effects of cancer therapies that can negatively impact quality-of-life and overall outcomes for women during and after cancer treatment. The Cardio-oncology research team at GUH plan to capitalize on their expertise in both cancer care and cardiology to develop a care pathway for cancer patients who are at increased risk of developing heart disease.

Establishment of a Cardio-Oncology assessment and surveillance pathway for breast cancer patients undergoing adjuvant systemic chemotherapy at GUH and the assessment of the feasibility of trialing this approach for risk assessment and early detection of CTRCD in a multicenter, prospective RCT which will inform future development of clinical services for cancer patients nationally and later internationally.

Study Design:

This study is a prospective, single arm, pilot feasibility study.

Study Population:

The study will focus on adult female patients diagnosed with stage I-III breast cancer (BC).

Data Analysis and Statistics:

The PCORE Investigators have established collaboration with biostatisticians at the INSIGHT SFI centre for data analytics within University of Galway for analysis of the multi-component dataset from UCARE. Questionnaire data to assess health related QoL (quality of life) and physical activity will be collected at baseline and at 6-monthly intervals at 3, 6 and 12 months throughout the study period. Clinically important differences in physical activity levels or HR-QoL scores will be recorded as per the tool specific scoring systems. Multivariate analysis will be performed for association between HRQoL measures and predictors in patients undergoing breast cancer treatment. Baseline to 6, 12, 18 and 24 month changes in HRQoL over time will be described in subgroups defined by their treatment characteristics and tumor and host response to therapy (both oncologic and cardio-toxic).

Bloods for Biobank specimens - Serum, whole blood, paxgene, plasma and serum

Understanding CARdiac Events in Breast Cancer

Understanding CARdiac Events in Breast Cancer - Pilot Cardio-Oncology Assessment and Surveillance Pathway for Breast Cancer Patients

To calculate the percentage of patients who successfully completed all guideline required investigations for baseline assessments, during and post chemotherapy surveillance i.e. Echocardiography, ECG, and Cardiac biomarkers (troponin and BNP).

To assess the incidence of CVD at baseline

To assess the incidence of CTRCD at all post-therapy timepoints./

Feasibility of collection of guideline-required imaging data, defined as the number of participants with successful collection of guidelines-required clinical data among patients with breast cancer undergoing systemic chemotherapy.

Feasibility of collection of guideline-required clinical data, defined as the number of participants with successful collection of guidelines-required clinical data among patients with breast cancer undergoing systemic chemotherapy.

Clinical Research Facility Galway

CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland

National University of Ireland, Galway, Ireland

Professor of Cardiovascular Research

Nervous System Diseases

Rare Diseases

Coronary Artery Disease

Hypertension

Aortic Dissection

Arrhythmias, Cardiac

Ischemia

Cerebrovascular Disorders

Coronary Disease

Myocardial Ischemia

Heart Valve Diseases

Brain Neoplasms

Myocarditis

Heart Neoplasms

Vascular Diseases

Arteriosclerosis

Arterial Occlusive Diseases

Dissection, Blood Vessel

Aneurysm

Syndrome

Acute Aortic Syndrome

Aortic Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Thoracic Neoplasms

Heart Tumor

Acute Graft Versus Host Disease

Diagnosis of coronary artery disease by clinical guidelines.

Diagnosis of arrhythmia by clinical guidelines. by clinical guidelines.

Diagnosis of heart valve disease by clinical guidelines.

Diagnosis of aortic dissection by clinical guidelines.

Diagnosis of cardiac messes by clinical guidelines.

Diagnosis of myocarditis by clinical guidelines.

Diagnosis of hypertension by clinical guidelines.

Diagnosis of cardiomyopathy by clinical guidelines.

Diagnosis of structural heart disease by clinical guidelines.

Diagnosis of ischemic cerebrovascular disease by clinical guidelines.

Diagnosis of hemorrhagic cerebrovascular disease by clinical guidelines.

Diagnosis of intracranial space occupying by clinical guidelines.

Observational; No Interventions were given.

Gouliang Li

Yang Yan

The etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and treatment are hot research topics in the study of cardiovascular and cerebrovascular diseases. This study intends to collect clinical data and biological specimen data of patients with cardiovascular and cerebrovascular diseases who meet the inclusion and exclusion criteria, and use multi-omics technology to deeply understand the pathogenic mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to construct early predictive prognostic models and provide a basis for effective treatment of clinical practice in patients with cardiovascular and cerebrovascular diseases.

Cardiovascular and cerebrovascular diseases refer to ischemic and hemorrhagic diseases of the heart, brain and body tissues caused by hyperlipidemia, blood viscosity, atherosclerosis, hypertension, etc. It is one of the major public health problems in the world. The etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and treatment are hot research topics in the study of cardiovascular and cerebrovascular diseases. This study intends to collect clinical data and biological specimen data of patients with cardiovascular and cerebrovascular diseases who meet the inclusion and exclusion criteria, and use multi-omics technology to deeply understand the pathogenic mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to construct early predictive prognostic models and provide a basis for effective treatment of clinical practice in patients with cardiovascular and cerebrovascular diseases.

Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics

Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics (PROSPECT): a National, Multicenter, Retrospective-prospective, Cohort Study

Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction, coronary revascularization, and stroke.

Incidence of patients' death from any cause.

Changes of serum myocardial zymogram level and ECG were used for diagnosing of myocardial infarction.

Incidence of percutaneous coronary intervention or coronary artery bypass grafting.

Stroke were assessed by radiologist using CT scan or other imaging test.

Xi'an Gaoxin Hospital

First Affiliated Hospital of Chongqing Medical University

General Hospital of Ningxia Medical University

Second Affiliated Hospital of Nanchang University

First Affiliated Hospital Xi'an Jiaotong University

Endocardiomyocardial biopsy

XiaoHong PAN

In this study, patients with endocardial myocardial biopsy were selected to observe the safety of the operation, and pathological examination was performed. If necessary, special tests such as viral examination, mass spectrometry and molecular biology were performed to confirm the diagnosis, and follow-up was performed.

Clinical Study of Endocardial Myocardial Biopsy

incidences of MACE-4(cardiovascular death, myocardial infarction, stroke and hospitalized unstable angina)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months.

Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.

NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.

NTproBNP above the upper limit of normal will trigger the initiation of heart failure therapy with counseling from a study investigator based on protocol specified algorithm.

Biomarker Guided Intervention

Bonnie Ky, MD, MSCE

Investigators will evaluate the safety and feasibility of a biomarker-guided cardioprotection strategy using NTproBNP, as compared to usual care, in breast cancer and lymphoma patients treated with anthracyclines.

This is a randomized, open-label pilot trial of a biomarker-guided strategy using NT-proBNP to identify and treat patients with a high risk of cancer therapy-related cardiotoxicity. Patients will be enrolled and randomized prior to initiation of anthracycline-based therapy and followed for 12 months with blood samples, echocardiography, and patient reported outcomes surveys. The overall hypothesis is that a biomarker guided treatment strategy that initiates neurohormonal antagonists in breast cancer or lymphoma patients who have increases in NT-proBNP prior to, during, or after anthracyclines will be feasible, well-tolerated, and result in attenuation of cardiotoxicity, compared to standard care.

Serial monitoring of NTproBNP during chemotherapy will be used to identify high-risk patients in the intervention arm; patients who experience elevations in NTproBNP will be initiated and titrated on a personalized regimen of neurohormonal antagonists. Patients in the usual care arm will not have serial NTproBNP monitoring and will be managed according to usual care.

Pilot Study of an NTproBNP Guided Strategy of Cardioprotection

A Randomized, Open Label Pilot Trial of a Biomarker Guided Strategy of Cardioprotection in Patients With Lymphoma or Breast Cancer Treated With Anthracyclines

Change in global longitudinal strain by echocardiogram

Change in circumferential strain by echocardiogram

Change in hsTnT measured in batches from banked samples

Change in GDF-15 measured in batches from banked samples

Change in MPO measured in batches from banked samples

Change in NTproBNP measured in batches from banked samples for all patients on both arms

Change in total weekly leisure activity in METS (assessed by GODIN Leisure Time Exercise Questionnaire)

Change in MD Anderson Symptoms Inventory - Heart Failure (MDASI-HF). Higher scores indicate increased symptom severity or symptom distress.

Change in Patient Reported Outomes Information System (PROMIS) Fatigue Score. A higher score corresponds to higher levels of reported fatigue.

Change in Patient Reported Outomes Information System (PROMIS) Global Health score. Higher scores indicate a healthier patient.

Change in NCI Patient Reported Outcomes - Common Terms and Criteria for Adverse Events (PRO CTCAE).

Incidence of anthracycline chemotherapy being held or discontinued secondary to side effects or toxicity

percent of eligible patients who are randomized

percent of randomized patients who complete the study per protocol

percent of study activities completed in window

Compliance by PROMIS Scale v1.0 for patients in the biomarker guided arm initiated on heart failure medications

Maximum tolerated dosage of neurohormonal antagonist medications for patients in the biomarker-guided arm with NTproBNP above upper limit of normal

Rate of Grade 2 or higher adverse events by CTCAEv5.0

Change in clinically measured NTproBNP following initiation of neurohormonal antagonists in patients with NTproBNP above upper limit of normal in the biomarker guided arm

Change in core-lab quantitated left ventricular ejection fraction

Incidence of cardiotoxicity defined as LVEF decline of at least 10% to less than 50%

Incidence of new or worsened clinical heart failure, defined as urgent or new office or emergency department visit or hospitalization for HF, adjudicated by a clinical events committee

Frequency of cancer treatment interruptions due to cardiotoxicity

National Heart, Lung, and Blood Institute (NHLBI)

Abramson Cancer Center at Penn Medicine

Participants randomized to observational arm will receive standard oncological followup and care.

Intervention arm receives standard oncological followup and care + subclinical cardiotoxicity surveillance and treatment.

Intervention arm receives cardiology assessment and intervention.

Subclinical cardiotoxicity surveillance and treatment

Elham Hedayati, MD, PhD

Laila Hubbert, MD, PhD

The main objective of this randomized controlled trial is to test the association between standard cardiac risk factors, biomarkers and parameters of echocardiography, electrocardiography, and cardiac magnetic resonance imaging, (predictors) and subsequent occurrence, frequency and severity of clinical or subclinical cardiotoxicity (outcome) within and between-groups, before start of chemotherapy, during treatment and at 1, 5, and 10 years after the completion of the chemotherapy among women with early breast cancer.

Rationale for the study:

Breast cancer is the most common cancer among Swedish women, accounting for a third of all cancer cases among females. The breast cancer incidence has increased from 2596 to more than 8000 breast cancer diagnosis 2011. During the past 40 years, the age-adjusted incidence has doubled. Early adjuvant therapy reduces the risk of dying with about 50%. (Early adjuvant therapies; chemotherapy, antibodies, endocrine therapy, and radiotherapy). Treatment advances have improved survival rates, but treatment-related cardiotoxicity (CT) remains a substantial problem.

In general, earlier treatment of cardiotoxicity offers the best chances of preventing or ameliorating clinical cardiotoxicity. Risk factors should be modified or reduced by treating elevated blood pressure, normalizing lipids, encouraging weight reduction and smoking cessation. Patient-tailored therapy is now possible, especially given the availability of different chemotherapy regimens, safer anthracycline analogs such as liposomal doxorubicin, and cardioprotective medications such as angiotensin converting enzyme (ACE)-inhibitors, angiotensin receptor blockers, and b-blockers. It is now suggested that new cardiac biomarkers and ultrasound techniques can detect cardiotoxicity in its early, subclinical, stages. The investigators hypothesized that biomarkers can be used to detect subclinical cardiotoxicity and that detecting early signs of cardiotoxicity might reduce the number, time-to-onset, and severity of cardiotoxic events.

In present proposal the investigators aim in a randomized study to compare primary cardiac preventive measurements versus standard care.

Objectives of the trial:

1. Primary objective In a randomized study to investigate the cumulative incidence of cardiotoxic events, per randomized arm, before start of chemotherapy, during treatment and at 1, 5, and 10 years after the completion of the chemotherapy.
2. Secondary Objectives To compare the number, time-to-onset, and severity of cardiotoxic events in an experimental group assessed and treated for subclinical cardiotoxicity before start of chemotherapy, during treatment and at 1, 5, and 10 years after the completion of the chemotherapy and a control group receiving standard of care without early assessment for subclinical cardiotoxicity. Data on the same variables will be collected from both groups before start of chemotherapy, during treatment and at 1, 5, and 10 years. Data from the experimental group will be used in real time to guide therapy, but data from the control group will be not be analyzed until after the end of the study.

To assess subclinical cardiotoxicity with serum concentrations of biomarkers, tissue Doppler and strain echocardiography, electrocardiography, and magnetic resonance imaging, as well as with standard cardiac risk assessment based on standard risk factors: a history of heart disease, increasing age, obesity, hypertension, diabetes mellitus, hypercholesterolemia, smoking, parasternal radiotherapy, and the cumulative dose of anthracyclines and trastuzumab.

To assess the association between primary treatment of existing standard cardiac risk factors, biomarkers and parameters of echocardiography, electrocardiography, and cardiac magnetic resonance imaging, (predictors) and subsequent occurrence of clinical or subclinical cardiotoxicity of cardiotoxicity (outcome) within and between-groups, over time.

To examine how a diagnosis of breast cancer and the development of cardiotoxicity influences women's quality of life.

The Cardio-Oncology Breast Cancer Study

Effects of Identifying and Treating Early, Subclinical Cardiotoxicity on the Long-Term Incidence of Clinical Cardiotoxicity in Women With Breast Cancer, A Prospective Randomized Study: The Cardio-Oncology Breast Cancer Study (COBC)

The cumulative incidence of clinical or subclinical cardiotoxicity, per randomized arm, in women with breast cancer at 1 year after treatment with neo- or adjuvant chemotherapy.

Karolinska University Hospital

M.D., Ph.D. Senior Consultant

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Peripheral Arterial Disease

Diabetes Mellitus

Peripheral Vascular Diseases

Atherosclerosis

In this group, physicians will use standard care plus the clinical decision aid.

In this group, physicians will use standard care only.

The clinical decision aid tool will be used at the subject's first visit (Week 0), Week 12 and Week 24.

Clinical Decision Aid

Cardiology clinic visits will take place at the subjects first visit (Week 0), Week 12 and Week 24.

Standard Care

Sherry-Ann Brown, MD, PhD

This is a single-center, double-arm, open-label, randomized feasibility study that will determine whether a novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists, will favorably impact appropriate medication use and cardiac imaging surveillance, and will improve clinician and patient decision-making, perception, and behavior towards cardioprotective medication usage and cardiovascular disease imaging utilization.

For this feasibility study, the researchers will create the clinical decision aid and test the central hypothesis that this novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists and will favorably impact appropriate medication use and cardiac imaging surveillance. The hypothesis is supported by preliminary data suggesting that an initial and rudimentary version of the clinical aid increases appropriate medication use and imaging follow-up in cardio-oncology patients. Success will be determined by ≥85% of clinic visits using the clinical decision aid resulting in pursuit of medication use and cardiac imaging surveillance patterns commensurate with recommendations specific to cancer survivors, with overall rates the same or higher than the group without the clinical decision aid, as well as overall favorable patient and physician focus group comments and survey responses.

PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study

The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.

The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Understanding CARdiac Events in Breast Cancer	NCT05921279	Breast Cancer Cardiotoxicity Cardiomyopathie... Chemotherapeuti... Heart Failure Oncology		18 Years - 90 Years	National University of Ireland, Galway, Ireland
Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics	NCT06001073	Coronary Artery... Arrhythmias, Ca... Heart Valve Dis... Aortic Dissecti... Heart Neoplasms Myocarditis Hypertension Cardiomyopathie... Structural Hear... Ischemic Cerebr... Hemorrhagic Cer... Brain Neoplasms	Observational; ...	3 Years - 80 Years	First Affiliated Hospital Xi'an Jiaotong University
Clinical Study of Endocardial Myocardial Biopsy	NCT05718128	Myocarditis Cardiomyopathie... Heart Failure Cardiac Tumor Endocardiomyoca...	Endocardiomyoca...	18 Years - 80 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Pilot Study of an NTproBNP Guided Strategy of Cardioprotection	NCT04737265	Cardiotoxicity Toxicity Due to... Breast Cancer Lymphoma Cardiomyopathie... Heart Failure	Biomarker Guide...	18 Years -	Abramson Cancer Center at Penn Medicine
The Cardio-Oncology Breast Cancer Study	NCT02571894	Cardiotoxicity Cardiomyopathie... Breast Cancer	Subclinical car...	18 Years -	Karolinska University Hospital
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study	NCT05377320	Heart Failure Coronary Artery... Peripheral Arte... Ischemia Hypertension Diabetes Mellit... Cardiomyopathie... Cardiotoxicity	Clinical Decisi... Standard Care	18 Years -	Medical College of Wisconsin

Spots Global Cancer Trial Database for cardiomyopathies