Heart and Blood Diseases

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Heart Failure

Prostatic Neoplasms

Atrial Fibrillation

Arrhythmias, Cardiac

Cardiotoxicity

Tachycardia

Tachycardia, Supraventricular

Heart Diseases

Cardiac Conduction System Disease

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Hormones

Abiraterone Acetate

Androgen Antagonists

Hormone Antagonists

Androgen-deprivation therapies including L02 (sex hormones used in treatment of neoplastic diseases), and G03 (sex hormones)

L02 (sex hormones used in treatment of neoplastic diseases) and G03 (sex hormones)

Abiraterone associated with prednisone is used in prostate cancer. Abiraterone is a selective small-molecule inhibiting cytochrome P450 17A1 (CYP17A1), a key enzyme in androgen synthesis.

CYP17A inhibition is also responsible for mineral corticosteroid related adverse events as hypokaliemia, fluid retention, and hypertension. Primary hyperaldosteronism is associated with cardiovascular toxicities such as atrial fibrillation and cardiac failure. Other androgen-deprivation therapies are not associated with increased mineral corticosteroid level.

This study investigates reports of cardiovascular toxicities for treatment including L02 (sex hormones used in treatment of neoplastic diseases), and G03 (sex hormones) used in prostate cancer in the French pharmacovigilance database and in the EudraCT database.

Due to its peculiar pharmacology, abiraterone is potentially associated with more cardiotoxicity as compared to other androgen-deprivation therapies. This study investigates the main characteristics of patients affected by cardiovascular side effects of which supraventricular arrhythmias (including atrial fibrillation, atrial flutter, supraventricular tachycardia), and cardiac failure imputed to drugs classified as L02, and G03 according to anatomical therapeutic chemical (ATC) classification. A causality assessment according to the World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) is systematically applied.

cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study

Cardiotoxicity of Abiraterone in the National French Pharmacovigilance Database and in the European Clinical Trials Database (EudraCT)

Analysis of disproportionality of reports for cardiotoxicity associated with abiraterone as compared to enzalutamide by performing a case- non-case study

Compare the reporting of suspected drug-induced supraventricular arrhythmias with abiraterone as compared to enzalutamide by performing a disproportionality analysis

Compare the reporting of drug-induced cardiac failure with abiraterone as compared to enzalutamide by performing a disproportionality analysis

Compare the reporting of drug-induced cardiac failure and/or supraventricular arrhythmias with abiraterone as compared to other androgen-deprivation therapies by performing a disproportionality analysis

Description of other mineralocorticoid related adverse events (hypokaliemia, fluid retention, and hypertension) when the cardio toxicity occurs

Description of the population of patients having a cardio-vascular adverse event

Description of the duration of treatment when the toxicity happens (role of cumulative dose)

Description of the drug-drug interactions associated with adverse events

Causality assessment of reported cardiovascular events according to the WHO-UMC system

Groupe Hospitalier Pitie-Salpetriere

MD, PhD

Nervous System Diseases

Rare Diseases

Coronary Artery Disease

Hypertension

Aortic Dissection

Cardiomyopathies

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

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Breast Neoplasms

Pancreatic Neoplasms

Carcinoma, Renal Cell

Liver Neoplasms

Head and Neck Neoplasms

Kidney Neoplasms

Spinal Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Bone Neoplasms

Bone Diseases

Spinal Diseases

Pancreatic Cancer

Renal Cell Carcinoma

Hematinics

Liver Extracts

Patients having radiation therapy for treatment of brain cancer.

Patients having radiation therapy for treatment of breast cancer.

Patients having radiation therapy for treatment of head and neck cancer.

Patients having radiation therapy for treatment of kidney cancer.

Patients having radiation therapy for treatment of liver cancer.

Patients having radiation therapy for treatment of pancreatic cancer.

Patients having radiation therapy for treatment of prostate cancer.

Patients having radiation therapy for treatment of spinal cancer.

Patients having radiation therapy for treatment of cardiac arrhythmia

Shona Silvester

Natalie Plant

Principal Investigator

Paul Keall

This study will develop a whole-of-body markerless tracking method for measuring the motion of the tumour and surrounding organs during radiation therapy to enable real-time image guidance.

Routinely acquired patient data will be used to improve the training, testing and accuracy of a whole-of-body markerless tracking method. When the markerless tracking method is sufficiently advanced, according to the PI of each of the data collection sites, the markerless tracking method will be run in parallel to, but not intervening with, patient treatments during data acquisition.

This observational study will access routinely acquired radiation therapy treatment data from 300 patients including brain, breast, head and neck, kidney, liver, pancreas, prostate, spine and cardiac anatomic sites. At least 30 patients will be recruited from each anatomic site to enable sufficient data for the markerless tracking method training, testing and validation. The clinical data will be used to develop, train, test and validate a markerless target tracking method.

After the treatment, the ground truth and the variability in the ground truth will be computed. The patient images, the markerless tracking results, the ground truth and the variability will be uploaded to an in-house developed clinical trial learning system. Uploading additional data to the learning system automatically triggers the model building of the deep learning system. In this manner, the learning system gets both more accurate and more robust with each patient accrued. As the patient data accrues, the primary hypothesis of targeting accuracy can be tested.

The developed markerless tracking software will be applied by study personnel to the treatment imaging data for each anatomic site using five-fold cross-validation where 80% of the data is used for training and the remaining unseen 20% of the data is used for testing. Target positions produced by the markerless tracking will be compared with a 'ground truth'.

LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology

After study completion, de-identified (non-coded, non-re-identifiable) data will be available to researchers for further scientific research. Information about data sharing will be provided to study participants in the Patient Information Sheet.

Proportion of markerless tracking within 5 mm of the ground truth for each of nine anatomical sites (cohorts)

Proportion of radiation therapists considering the markerless tracking system acceptable using a survey

Princess Alexandra Hospital, Brisbane, Australia

Calvary Mater Newcastle, Australia

Western Sydney Local Health District

Austin Health

Peter MacCallum Cancer Centre, Australia

University of Sydney

Respiratory Tract (Lung and Bronchial) Diseases

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Renal Insufficiency

Respiratory Insufficiency

Diabetes Mellitus

Stroke

Dementia

Lung Diseases

Pulmonary Disease, Chronic Obstructive

Peripheral Arterial Disease

Peripheral Vascular Diseases

Alcoholism

Respiratory Tract Diseases

Mental Disorders

Psychotic Disorders

Chronic Disease

Disease Attributes

Lung Diseases, Obstructive

Alcohol-Related Disorders

Substance-Related Disorders

Atherosclerosis

Respiration Disorders

Chronic Graft Versus Host Disease

Central Nervous System Depressants

Anesthetics

The OPTI-AGED group will receive a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia.

The control group will not benefit from the OPTI-AGED intervention but patients will receive the usual care.

OPTI-AGED is composed of a multi-parametric optimization strategy.

OPTI-AGED

Usual Care

MOLLIEX Serge, MD

With the increasing aging population demographics and life expectancies, the number of very elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group.

Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes.

Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.

The population is expanding and aging. With the increasing aging population demographics and life expectancies, the number of very elderly patients (age ≥ 75) undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group. In 2010, patients aged 75 yrs and over represented only 2.1% of patients undergoing high risk surgery in France (PMSI database), but concentrated 27% of in-hospital deaths.

Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes. Meta-analyses have demonstrated that goal directed hemodynamic therapy significantly reduced mortality and surgical complications in high-risk patients. A lung-protective ventilation strategy in high-risk patients undergoing major abdominal surgery was associated with improved clinical outcome. Retrospective studies indicated that a combination of excessive depth of anesthesia, hypotension and low anesthesia requirement resulted in increased mortality. These approaches of peroperative care remain discussed in the literature and have also to be incorporated in the common clinical practice. Moreover, few of these reviews performed a sensitive analysis in the elderly.

Whether a multi-parametric optimization strategy of anesthesia including several specific interventions will impact the short-term postoperative major morbidity and mortality in elderly is not known. The addition of depth of anesthesia monitoring to hemodynamic monitoring and goal directed hemodynamic therapy may improve tissue perfusion by reducing hemodynamic side effects of anesthetic agents, particularly in elderly where the therapeutic window of these agents is reduced. The effects of low protective ventilation may also by additive to the previous measures by reducing the perioperative build-up of oxygen debt. Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.

Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality

The OPTI-AGED Study : Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality in Elderly Patients. A Randomized, Multicentre, Prospective Controlled Study

One or more of major postoperative complications : acute kidney injury (defined by Kidney disease : improving Global Outcomes (KDIGO) stage 1 or higher), acute myocardial infarction, heart failure, stroke, development of sepsisand septic shock, acute respiratory failure requiring non-invasive ventilation or intubation, delirium) will be reported in the source folder of the patients, and the mortality will be also focused. The goal of this study is to decrease this incidence.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study	NCT03243604	Arrhythmias, Ca... Atrial Fibrilla... Tachycardia, Su... Cardiac Failure	L02 (sex hormon...	18 Years -	Groupe Hospitalier Pitie-Salpetriere
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
LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology	NCT05184790	Arrhythmias, Ca... Breast Cancer Prostatic Cance... Brain Cancer Kidney Cancer Head and Neck C... Liver Cancer Pancreatic Canc... Spinal Neoplasm		18 Years -	University of Sydney
Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality	NCT02668250	Coronary; Ische... Arrhythmias, Ca... Heart Failure Peripheral Vasc... Dementia Stroke Pulmonary Disea... Respiratory Ins... Alcoholism Cancer Diabetes Renal Insuffici...	OPTI-AGED Usual Care	75 Years -	Centre Hospitalier Universitaire de Saint Etienne
cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study	NCT03243604	Arrhythmias, Ca... Atrial Fibrilla... Tachycardia, Su... Cardiac Failure	L02 (sex hormon...	18 Years -	Groupe Hospitalier Pitie-Salpetriere
Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality	NCT02668250	Coronary; Ische... Arrhythmias, Ca... Heart Failure Peripheral Vasc... Dementia Stroke Pulmonary Disea... Respiratory Ins... Alcoholism Cancer Diabetes Renal Insuffici...	OPTI-AGED Usual Care	75 Years -	Centre Hospitalier Universitaire de Saint Etienne

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