Diseases and Abnormalities at or Before Birth

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Musculoskeletal Diseases

Nervous System Diseases

Rare Diseases

Congenital Abnormalities

Cardiotoxicity

Myositis

Myocarditis

Pericarditis

Cardiovascular Abnormalities

Idiopathic Inflammatory Myopathy

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Gadolinium-enhanced magnetic resonance imaging of the heart before the first cycle of chemotherapy

Cardiac MRI

A smart cloth recording cardiac and hemodynamic parameters will be worn by patients during 42 days. Replaced by a holter monitor if the smart cloth is refused or not tolerated by the patient.

Smart cloth

Blood samples (plasma, serum, DNA, stem cells, immune cells) taken as part of the study will be stored in a biological sample collection. These samples may be used for further analysis not described in the initial protocol but which may be useful for investigation or in light of advances in scientific knowledge.

Biobanking

Mariana Mirabel, MD

Our knowledge on cardiovascular side effects of immune checkpoint inhibitors (ICIs) is restricted to this date to observational retrospective data (mainly case series and pharamcovigilance analysis). We aim at assessing the incidence of cardiovascular adverse side effects of ICIs by means of a prospective interventional single centre study using multiple biomarkers.

Immune checkpoint inhibitors (ICIs) are drastically improving cancer prognosis. Cardiovascular adverse side effects of ICIs are though to be rare but may be responsible for \~50% death rates.

Prospective screening for cardiovascular and muscular immune related side effects has not been undertaken independently from the industry.

The aim is to describe the incidence of these side effects by means of serial assessment in patients undergoing ICI therapy for cancer. Biomarkers as ECG, echocardiography, cardiac magnetic resonance imaging and long-term ECG monitoring will be undertaken at inclusion (before ICI therapy is started), and during the first cycle treatments and at 6 months follow-up.

Mean endpoint encompasses cardiovascular and muscular adverse side effects between the 2nd and the 3rd ICI cycle. Secondary endpoints include cardiovascular and muscular adverse side effects at 6 months follow-up, and the incidence of individual side effects.

4 ancillary studies based on patients' blood biobanking are also planned. Their objectives are:

* to assess sensitivity of heart failure biomarkers in predicting cardiovascular events under ICI,
* to assess sensitivity of cytokine biomarkers in predicting cardiovascular events under ICI,
* to bank cells to induce cardiomyocytes from stem cells
* to bank DNA to identify genetic factors related to occurrence of cardiovascular events under ICI

Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors

Atteintes Myocardiques, péricardiques et Vasculaires Sous Simple et/ou Double immunothérapie Anti-cancéreuse Anti-PD1, antiPDL1 et Anti-CTLA4

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Incidence of a composite endpoint including myocarditis, pericarditis, acute coronary syndrome, acute heart failure, subclinial cardio-toxicity, high degree conduction abormalities or ventricular sustained arrythmias, cardiovascular death.

Incidence of a composite endpoint including vasculitis or myositis.

Burden of extrasystole, low degree conduction disorders

Characterization of risk predictors for occurrence of cardiovascular adverse drug event, among the following: socio-demographic characteristics, oncologic characteristics, previous treatments, serum biomarkers, patient assessment on ESC-SCORE and ACC/AHA ASCVD risk scoring systems, immune status, cardiac characteristics on imaging.

Fédération Française de Cardiologie

BioSerenity

Assistance Publique - Hôpitaux de Paris

Cardiomyopathies

Heart Diseases

Acute Graft Versus Host Disease

Antirheumatic Agents

Abatacept

Antineoplastic Agents, Immunological

Immunosuppressive Agents

Immunologic Factors

Abatacept (10 mg/kg) will be administered IV after randomization, again at 24 hours after first study drug treatment, at 14 days after first study drug treatment and an optional 4th dose at 28 days.

Placebo will be administered at the same intervals.

Up to 4 study drug infusions at 10 mg/kg, IV

Drug: Standard of care Local standard of care per written policies or guidelines Other Name: SoC

Abatacept plus

Drug: Standard of care Local standard of care per written policies or guidelines Other Name: SoC

Placebo

Hannah K Gilman, MS

Kiranbir Josan, MD

Eric Yang, MD

Hayder Hashim

Mohammed v

Mohammed Alomar

Jeanne DeCara

Ryan Daly

Ryan Daly, MD

Charles Porter

Charles Porter, MD

Amit Arbune

Amit Arbune, MD

Maxwell Afari

Maxwell Afari, MD

Joban Vaishnav

Daniel Zlotoff, MD, PhD

Kerry Reynolds, MD

Abul Aritizia, MD

Aarti Asnani, MD

Omar Siddiqi

Omar Siddiqi, MD

Anju Nohria, MD

Salim Hayek, MD

Joerg Herrmann

Joerg Herrmann, MD

Amna Zafar

Jayant Raikhelkar

Dipti Gupta, MD

Brian Jensen, MD

Rohit Moudgil

Nicholas Trask

Deborah Sundlof

Michael Fradley

Valentyna Ivanova

Ivanova Ivanova, MD

Saketh Nadimpalli

Vlad Zaha, MD

Nicolas Palaskas

Nicolas Palaskas, MD

Anees Daud, MD

Brijesh Patel

Brijesh Patel, MD

Manmeet Singh

Margot Davis

Margot Davis, MD

Darryl Leong

Darryl Leong, MD

The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure.

This investigator-initiated randomized trial is being conducted to test whether abatacept, as compared to placebo, is associated with a reduction in MACE among participants who develop myocarditis after treatment with an ICI. Immune checkpoint inhibitors leverage the immune system to treat a wide variety of cancers. Myocarditis is an uncommon immune related adverse event (irAE) secondary to treatment with an ICI. The guideline recommended treatment for ICI myocarditis is cessation of the ICI and administration of corticosteroids. However, despite administration of corticosteroids, the rate of MACE with ICI myocarditis is high. Data from multiple independent international cohorts have shown that the rate of MACE with ICI myocarditis despite administration of corticosteroids ranges from 25-50%.For comparison, the rate of MACE with myocarditis unrelated to an ICI is \<5%.

Abatacept is a selective co-stimulation modulator that inhibits T cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking its interaction with CD28. This interaction provides a costimulatory signal necessary for full activation of T lymphocytes. In animal studies of ICI myocarditis, the administration of abatacept led to a reduction in cardiac immune activation and an increase in survival. In retrospective unpublished clinical data, the administration of abatacept to participants with ICI myocarditis on corticosteroids was associated with a reduction in risk of MACE. There are no prospective studies testing whether abatacept is effective among participants with ICI myocarditis. Therefore, the primary aim of this trial is to test in a randomized double-blind placebo-controlled study whether abatacept, administered concurrently with corticosteroids, is associated with a reduction in MACE among participants with recently diagnosed ICI myocarditis

Abatacept in Immune Checkpoint Inhibitor Myocarditis

AbatacepT foR ImmUne Checkpoint Inhibitor Associated Myocarditis (ATRIUM): A Phase 3, Investigator-Initiated, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in ICI Myocarditis

The rates of a composite of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure.

The rates of the following between groups: cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure

The worst score on a 7-point ordinal myocarditis severity scale during the 6 month period from first study treatment. The 7-point ordinal myocarditis severity scale is as follows with more severe outcomes ranked with a higher number:

1. - No component of the primary endpoint;
2. - Incident heart failure;
3. - Significant bradyarrhythmia;
4. - Significant ventricular tachyarrhythmias;
5. - Cardiogenic shock;
6. - Sudden cardiac arrest;
7. - Cardiovascular death;

The proportion of participants in each group with a \>50% increase in serum troponin value at any time during the incident hospitalization and following administration of study drug.

The rates of a composite of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure plus the proportion of participants in each group with a \>50% increase in serum troponin value at any time during the incident hospitalization and following administration of study drug.

Clinical status at visit 6 (day 90) on an ordinal scale with highest being the worst:

1. - Alive and off corticosteroids for myocarditis;
2. - Alive and on corticosteroids (provide dose) for myocarditis;
3. - Alive and on cellcept (provide dose) for myocarditis;
4. - Alive and on both corticosteroids (provide dose) and cellcept (provide dose) for myocarditis
5. - Dead (cancer, cardiovascular or other).

Clinical status at visit 7 (6 months) with the highest being the worst:

1. - Alive and off corticosteroids for myocarditis;
2. - Alive and on corticosteroids (provide dose) for myocarditis;
3. - Alive and on cellcept (provide dose) for myocarditis;
4. - Alive and on both corticosteroids (provide dose) and cellcept (provide dose) for myocarditis
5. - Dead (cancer, cardiovascular or other).

The proportion of patients in each group with a fatal and non-fatal DVT and PE will be compared.

Rates of other immune-related adverse events between the two groups will be compared.

Bristol-Myers Squibb

Massachusetts General Hospital

Director, Cardio-Oncology Program

Neoplasms

Coronary Artery Disease

Hypertension

Aortic Dissection

Arrhythmias, Cardiac

Ischemia

Cerebrovascular Disorders

Coronary Disease

Myocardial Ischemia

Heart Valve Diseases

Brain Neoplasms

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

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

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Influenza, Human

Rhabdomyolysis

Vaccines

Non-Interventional

A retrospective, observational study conducted on cancer patients receiving a drug that blocks certain proteins made by some types of immune system cells

Study to Determine if the Flu Vaccine Increases the Risk of Muscle Damage in Participants Taking Drugs That Block Certain Proteins Made by Some Types of Immune System Cells

Risk of Muscle Damage in Cancer Patients Exposed to the Influenza Vaccine While Receiving Checkpoint Inhibitor Therapies: A Nested Case Control Study Using Claims Data

Heart Failure

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

Atherosclerosis

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Bone Density Conservation Agents

Calcium

Calcium, Dietary

* Electrocardiogram (ECG).
* Echocardiogram: A comprehensive evaluation of systolic and diastolic function, ventricular and atrial geometry will be performed. Special attention will be given to acquire a 3D measurement of left ventricular ejection fraction (LVEF) and to perform deformation imaging of left ventricle (global longitudinal strain (GLS)). The right ventricular function will be evaluated by tricuspid annular plane systolic excursion (TAPSE) and peak systolic velocity S' derived from color coded tissue Doppler imaging (TDI). Diastolic dysfunction will be based on average E/e' ratio \> 15 and left atrial (LA) area \> 30 cm2.

Cardiology consultation

Calcium score. This will be performed at baseline, 12 and 24 months. The scans at 12 and 24 months will be combined, if possible, with standard of care scans for cancer treatment.

Chest Computed Tomography (CT) without contrast

* FMD
* PAT

This aspect of the study will only be performed in the patients included by the Antwerp University Hospital due to organizational/practical issues.

Non-invasive endothelial function tests

An ECG will be taken prior to each ICI cycle during the first three months of treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors	NCT04586894	Cancer Immune Defect Cardiovascular ...	Cardiac MRI Smart cloth Biobanking	18 Years -	Assistance Publique - Hôpitaux de Paris
Abatacept in Immune Checkpoint Inhibitor Myocarditis	NCT05335928	Myocarditis Acu... Cancer	Abatacept plus Placebo	18 Years -	Massachusetts General Hospital
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
Study to Determine if the Flu Vaccine Increases the Risk of Muscle Damage in Participants Taking Drugs That Block Certain Proteins Made by Some Types of Immune System Cells	NCT03644498	Cancer	Non-Interventio...	18 Years -	Bristol-Myers Squibb
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
Abatacept in Immune Checkpoint Inhibitor Myocarditis	NCT05335928	Myocarditis Acu... Cancer	Abatacept plus Placebo	18 Years -	Massachusetts General Hospital
Extensive CArdioVAscular Characterization and Follow-up of Patients Receiving Immune Checkpoint Inhibitors	NCT05699915	Cancer Immune-related ... Cardiac Abnorma... Immune Checkpoi... Diastolic Dysfu... Atherosclerosis Cardiotoxicity	Cardiology cons... Chest Computed ... Non-invasive en... Electrocardiogr... Extra serum sam...	18 Years -	Algemeen Ziekenhuis Maria Middelares
Randomized Controlled Study Evaluating the Efficacy of Hypnosis in Nuclear Medicine	NCT06116084	Cancer Myocarditis Alzheimer Disea... Parkinson	Ericksonian Hyp... Hypnosis	18 Years - 80 Years	Central Hospital, Nancy, France
Multiparametric Cardiac MRI in Patients Under CAR T-cell Therapy	NCT05414162	DLBCL Multiple Myelom... Cytokine Releas... Myocarditis CAR T-cell Ther... ALL PCBCL Follicular Lymp... MCL	Cardiac MRI	18 Years -	University Hospital, Bonn
Contribution of Cardiac MRI in the Early Diagnosis of Myocarditis Induced by Immunotherapy	NCT05125965	Myocarditis	additional time...	18 Years -	Centre Chirurgical Marie Lannelongue

Spots Global Cancer Trial Database for myocarditis

Every month we try and update this database with for myocarditis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for myocarditis

Every month we try and update this database with for myocarditis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for myocarditis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.