DeBakey Cardiovascular Magnetic Resonance Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiovascular Magnetic Resonance.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Houston Methodist DeBakey Cardiovascular Magnetic Resonance Study
Overview
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
- Diagnostic test Cardiovascular Magnetic Resonance
Patients will undergo various CMR techniques designed to assess cardiovascular structure and function, tissue characteristics, and flow.
Primary outcome measures
- Mortality [Time frame: Through study completion, an average of once a year, up to 20 years]
- Heart Failure [Time frame: Through study completion, an average of once a year, up to 20 years]
- Heart and/or Lung Transplantation [Time frame: Through study completion, an average of once a year, up to 20 years]
- 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 outcome measures (4)
- Cardiac Interventions [Time frame: Through study completion, an average of once a year, up to 20 years]
- Arrhythmic [Time frame: Through study completion, an average of once a year]
- Acute myocardial infarction [Time frame: Through study completion, an average of once a year, up to 20 years]
- Acute Cerebrovascular Accident [Time frame: Through study completion, an average of once a year, up to 20 years]
Eligibility criteria
Inclusion criteria
- All patients presenting to the Houston Methodist CMR Laboratory with known or suspected cardiovascular disease.
Exclusion criteria
- Unable to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Houston Methodist Hospital — Houston
Publications
- Malahfji M, Bhugra P, Nguyen DT, Crudo V, Saeed M, Reardon M, Nagueh SF, Zoghbi WA, Graviss EA, Shah DJ. Cardiac MRI Evaluation of Determinants and Prognostic Implications of Right Ventricular Dysfunction in Aortic Regurgitation. Radiol Cardiothorac Imaging. 2025 Feb;7(1):e230389. doi: 10.1148/ryct.230389. PMID 39745324
- Tayal B, Faza NN, Nguyen DT, Malahfji M, Little S, Saeed M, Goel SS, Guha A, El-Tallawi KC, Graviss EA, Shah DJ. Association of secondary mitral regurgitation and right ventricular dysfunction among patients with non-ischaemic cardiomyopathy. Eur Heart J Cardiovasc Imaging. 2024 Nov 27;25(12):1627-1635. doi: 10.1093/ehjci/jeae134. PMID 38781428
- Tayal B, Debs D, Nabi F, Malahfji M, Little SH, Reardon M, Zoghbi W, Kleiman N, Shah DJ. Impact of Myocardial Scar on Prognostic Implication of Secondary Mitral Regurgitation in Heart Failure. JACC Cardiovasc Imaging. 2021 Apr;14(4):812-822. doi: 10.1016/j.jcmg.2020.11.004. Epub 2020 Dec 16. PMID 33341417
- Kitkungvan D, Yang EY, El Tallawi KC, Nagueh SF, Nabi F, Khan MA, Nguyen DT, Graviss EA, Lawrie GM, Zoghbi WA, Bonow RO, Quinones MA, Shah DJ. Extracellular Volume in Primary Mitral Regurgitation. JACC Cardiovasc Imaging. 2021 Jun;14(6):1146-1160. doi: 10.1016/j.jcmg.2020.10.010. Epub 2020 Dec 16. PMID 33341409
Identifiers
NCT: NCT04281823 · Pro00008766