NCT04281823: DEBAKEY-CMR

DeBakey Cardiovascular Magnetic Resonance Study

Recruiting now Last updated 24 February 2020

What this trial tests

trial testing Cardiovascular Magnetic Resonance in Cardiovascular Diseases in 100,000 participants. Currently enrolling.

Timeline

1 April 2008

Primary endpoint
1 April 2058

1 April 2058

Quick facts

Lead sponsor	Dipan Shah
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	100,000
Start date	1 April 2008
Primary completion	1 April 2058
Estimated completion	1 April 2058
Sites	1 location across United States

Drugs / interventions tested

• Cardiovascular Magnetic Resonance

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Dipan Shah — full company profile →

Who can join

Eligibility, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extracellular Volume in Primary Mitral Regurgitation.
   Kitkungvan D, Yang EY, El Tallawi KC, Nagueh SF, et al · · 2021 · cited 44× · PMID 33341409 · DOI 10.1016/j.jcmg.2020.10.010
2. Myocardial Scar and Mortality in Chronic Aortic Regurgitation.
   Malahfji M, Senapati A, Tayal B, Nguyen DT, et al · · 2020 · cited 37× · PMID 33241753 · DOI 10.1161/jaha.120.018731
3. Impact of Myocardial Scar on Prognostic Implication of Secondary Mitral Regurgitation in Heart Failure.
   Tayal B, Debs D, Nabi F, Malahfji M, et al · · 2021 · cited 21× · PMID 33341417 · DOI 10.1016/j.jcmg.2020.11.004
4. Examining the impact of inducible ischemia on myocardial fibrosis and exercise capacity in hypertrophic cardiomyopathy.
   Malahfji M, Senapati A, Debs D, Angulo C, et al · · 2020 · cited 9× · PMID 32994462 · DOI 10.1038/s41598-020-71394-z
5. Implications of myocardial strain in primary mitral regurgitation-a cardiovascular magnetic resonance study.
   Romano S, Kitkungvan D, Nguyen DT, El-Tallawi C, et al · · 2024 · cited 4× · PMID 39295523 · DOI 10.1093/ehjci/jeae245
6. Staging of Cardiac Adverse Remodeling in Moderate or Severe Aortic Regurgitation.
   Malahfji M, Nguyen DT, Bhugra P, Crudo V, et al · · 2025 · cited 3× · PMID 40758076 · DOI 10.1016/j.jcmg.2025.04.010
7. Association of secondary mitral regurgitation and right ventricular dysfunction among patients with non-ischaemic cardiomyopathy.
   Tayal B, Faza NN, Nguyen DT, Malahfji M, et al · · 2024 · cited 2× · PMID 38781428 · DOI 10.1093/ehjci/jeae134
8. Cardiac MRI Evaluation of Determinants and Prognostic Implications of Right Ventricular Dysfunction in Aortic Regurgitation.
   Malahfji M, Bhugra P, Nguyen DT, Crudo V, et al · · 2025 · PMID 39745324 · DOI 10.1148/ryct.230389