Clinical trial NCT04281823: DeBakey Cardiovascular Magnetic Resonance Study
Official title: Houston Methodist DeBakey Cardiovascular Magnetic Resonance Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular Disease
Cardiac Magnetic Resonance
Myocardial Fibrosis
Valvular Heart Disease
Ischemic Heart Disease
Cardiomyopathy
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients present to the Houston Methodist CMR Laboratory providing informed consent.

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.

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

Primary outcomes:
measure: Mortality
timeFrame: Through study completion, an average of once a year, up to 20 years
measure: Heart Failure
timeFrame: Through study completion, an average of once a year, up to 20 years
measure: Heart and/or Lung Transplantation
timeFrame: Through study completion, an average of once a year, up to 20 years
measure: Left Ventricular and/or Right Ventricular Assist Device Implantation
timeFrame: Through study completion, an average of once a year, up to 20 years
Secondary outcomes:
measure: Cardiac Interventions
timeFrame: Through study completion, an average of once a year, up to 20 years
measure: Arrhythmic
timeFrame: Through study completion, an average of once a year
measure: Acute myocardial infarction
timeFrame: Through study completion, an average of once a year, up to 20 years
measure: Acute Cerebrovascular Accident
timeFrame: Through study completion, an average of once a year, up to 20 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Dipan Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.