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DeBakey Cardiovascular Magnetic Resonance Study

Houston Methodist DeBakey Cardiovascular Magnetic Resonance Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04281823
Acronym
DEBAKEY-CMR
Enrollment
100000
Registered
2020-02-24
Start date
2008-04-01
Completion date
2058-04-01
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular Disease, Cardiac Magnetic Resonance, Myocardial Fibrosis, Valvular Heart Disease, Ischemic Heart Disease, Cardiomyopathy

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.

Interventions

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

Sponsors

Dipan Shah
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Unable to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
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 yearsAll-cause mortality, Cardiovascular mortality (acute Myocardial Infarction, sudden death, heart failure, cerebrovascular, procedural), and Non-cardiovascular mortality
Heart FailureThrough study completion, an average of once a year, up to 20 yearsCongestive heart failure
Heart and/or Lung TransplantationThrough study completion, an average of once a year, up to 20 years

Secondary

MeasureTime frameDescription
Cardiac InterventionsThrough study completion, an average of once a year, up to 20 yearsImplantable cardioverter-defibrillator (ICD), pacemakers, cardiac resynchronization therapy, coronary revascularization, valvular intervention, shunt closure
ArrhythmicThrough study completion, an average of once a yearSustained ventricular tachycardia, ventricular fibrillation, nonfatal cardiac arrest, appropriate ICD therapy
Acute myocardial infarctionThrough study completion, an average of once a year, up to 20 years
Acute Cerebrovascular AccidentThrough study completion, an average of once a year, up to 20 years

Countries

United States

Contacts

Primary ContactRachel Kronman-Gross, BS
rkronman-gross@houstonmethodist.org7134416539
Backup ContactMohamad Ghosn, PhD
mghosn@houstonmethodist.org7134419837

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026