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NCT Number: NCT04281823

DeBakey Cardiovascular Magnetic Resonance Study

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.

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Key information

Conditions

Cardiovascular Diseases Cardiomyopathies Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients presenting to the Houston Methodist CMR Laboratory with known or suspected cardiovascular disease.

Exclusion criteria

  • Unable to provide informed consent

Treatment and study plan

Cardiovascular Magnetic Resonance

Diagnostic Test

Patients will undergo various CMR techniques designed to assess cardiovascular structure and function, tissue characteristics, and flow.

Primary outcomes

  1. Mortality

    Time frame: Through 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

  2. Heart Failure

    Time frame: Through study completion, an average of once a year, up to 20 years

    Congestive heart failure

  3. Heart and/or Lung Transplantation

    Time frame: Through study completion, an average of once a year, up to 20 years

  4. Left Ventricular and/or Right Ventricular Assist Device Implantation

    Time frame: Through study completion, an average of once a year, up to 20 years

Secondary outcomes

  1. Cardiac Interventions

    Time frame: Through 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

  2. Arrhythmic

    Time frame: Through study completion, an average of once a year

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

  3. Acute myocardial infarction

    Time frame: Through study completion, an average of once a year, up to 20 years

  4. Acute Cerebrovascular Accident

    Time frame: Through study completion, an average of once a year, up to 20 years

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamad Ghosn, PhD

CONTACT

[email protected]

7134419837

Rachel Kronman-Gross, BS

CONTACT

[email protected]

7134416539

Sponsors and collaborators

Lead sponsor

Dipan Shah

Other

Registry information

Official study title

Houston Methodist DeBakey Cardiovascular Magnetic Resonance Study

Acronym: DEBAKEY-CMR

Important dates

Study start
2008
Primary completion
2058
Study completion
2058
First posted
Feb 24, 2020
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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