DeBakey Cardiovascular Magnetic Resonance Study

Study Overview
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Brief Summary
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While advancements in cardiac magnetic resonance (CMR) have improved image quality, it is unclear how these improvements are connected to the clinical evaluation of individuals with cardiovascular disease. The aim of this large prospective registry revolves around 4 key principles: 1) utilize CMR to gain additional pathophysiologic insights into cardiovascular disease, 2) understand how CMR compares to alternative cardiovascular diagnostic modalities, 3) determine how CMR affects clinical management decisions, and 4) establish a link between CMR findings and long term prognosis in patients with known or suspected cardiovascular disease. The ultimate aim is to utilize CMR to improve patient outcomes. CMR techniques to be studies include function, fibrosis, and flow. Focus areas include valvular heart disease, ischemic heart disease, cardiomyopathies, and vascular disease.

Detailed Description
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Patient Population, Recruitment, and Consent: Patients presenting to the Houston Methodist DeBakey CMR Laboratory will be enrolled from April 2008 to April 2038. It is expected that up to 100,000 patients may be enrolled during this period. Subjects will be identified based on their referral to the Houston Methodist DeBakey CMR Laboratory for MRI studies during the proposed study period. After enrollment, a registered nurse or physician will perform a thorough structured patient interview and/or review of electronic health records to document baseline medical history including cardiac risk factors, symptoms, medication usage, and prior procedure history. A small blood sample will be drawn and stored for future biomarker and/or genetic testing analysis. Annual follow up for clinical status will be performed via review of electronic health records; structured telephone interviews with the patients, relatives, and/or their health care providers; and/or the social security death index database.

Official Title
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Houston Methodist DeBakey Cardiovascular Magnetic Resonance Study

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Diagnostic Test: Cardiovascular Magnetic Resonance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients presenting to the Houston Methodist CMR Laboratory with known or suspected cardiovascular disease. Exclusion Criteria: Unable to provide informed consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiovascular Magnetic Resonance<br>All patients who present to the Houston Methodist CMR Laboratory | Diagnostic Test: Cardiovascular Magnetic Resonance<br>* Patients will undergo various CMR techniques designed to assess cardiovascular structure and function, tissue characteristics, and flow.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All-cause mortality, Cardiovascular mortality (acute Myocardial Infarction, sudden death, heart failure, cerebrovascular, procedural), and Non-cardiovascular mortality | Through study completion, an average of once a year, up to 20 years | 
| Heart Failure | Congestive heart failure | Through study completion, an average of once a year, up to 20 years | 
| Heart and/or Lung Transplantation |  | Through study completion, an average of once a year, up to 20 years | 
| Left Ventricular and/or Right Ventricular Assist Device Implantation |  | Through study completion, an average of once a year, up to 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Interventions | Implantable cardioverter-defibrillator (ICD), pacemakers, cardiac resynchronization therapy, coronary revascularization, valvular intervention, shunt closure | Through study completion, an average of once a year, up to 20 years | 
| Arrhythmic | Sustained ventricular tachycardia, ventricular fibrillation, nonfatal cardiac arrest, appropriate ICD therapy | Through study completion, an average of once a year | 
| Acute myocardial infarction |  | Through study completion, an average of once a year, up to 20 years | 
| Acute Cerebrovascular Accident |  | Through study completion, an average of once a year, up to 20 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Disease, Cardiac Magnetic Resonance, Myocardial Fibrosis, Valvular Heart Disease, Ischemic Heart Disease, Cardiomyopathy