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DeBakey Cardiovascular Magnetic Resonance Study

Recruiting
Conditions
Cardiovascular Diseases
Interventions
Diagnostic Test: Cardiovascular Magnetic Resonance
Registration Number
NCT04281823
Lead Sponsor
Dipan Shah
Brief Summary

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

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100000
Inclusion Criteria
  • All patients presenting to the Houston Methodist CMR Laboratory with known or suspected cardiovascular disease.
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Exclusion Criteria
  • Unable to provide informed consent
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Cardiovascular Magnetic ResonanceCardiovascular Magnetic ResonanceAll patients who present to the Houston Methodist CMR Laboratory
Primary Outcome Measures
NameTimeMethod
Heart FailureThrough study completion, an average of once a year, up to 20 years

Congestive heart failure

Left Ventricular and/or Right Ventricular Assist Device ImplantationThrough study completion, an average of once a year, up to 20 years
MortalityThrough study completion, an average of once a year, up to 20 years

All-cause mortality, Cardiovascular mortality (acute Myocardial Infarction, sudden death, heart failure, cerebrovascular, procedural), and Non-cardiovascular mortality

Heart and/or Lung TransplantationThrough study completion, an average of once a year, up to 20 years
Secondary Outcome Measures
NameTimeMethod
ArrhythmicThrough study completion, an average of once a year

Sustained ventricular tachycardia, ventricular fibrillation, nonfatal cardiac arrest, appropriate ICD therapy

Acute Cerebrovascular AccidentThrough study completion, an average of once a year, up to 20 years
Acute myocardial infarctionThrough study completion, an average of once a year, up to 20 years
Cardiac InterventionsThrough study completion, an average of once a year, up to 20 years

Implantable cardioverter-defibrillator (ICD), pacemakers, cardiac resynchronization therapy, coronary revascularization, valvular intervention, shunt closure

Trial Locations

Locations (1)

Houston Methodist Hospital

🇺🇸

Houston, Texas, United States

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