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Clinical Trial NCT04281823 (DEBAKEY-CMR) for Cardiovascular Diseases is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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DeBakey Cardiovascular Magnetic Resonance Study (DEBAKEY-CMR)

Recruiting
Clinical Trial NCT04281823 (DEBAKEY-CMR) is an observational study for Cardiovascular Diseases that is recruiting. It started on 1 April 2008 with plans to enroll 100,000 participants. Led by Dipan Shah, it is expected to complete by 1 April 2058. The latest data from ClinicalTrials.gov was last updated on 24 February 2020.
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.

Official Title

Houston Methodist DeBakey Cardiovascular Magnetic Resonance Study

Conditions
Cardiovascular Diseases
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • DEBAKEY-CMR
  • Pro00008766
NCT ID Number
Start Date (Actual)
2008-04-01
Last Update Posted
2020-02-24
Completion Date (Estimated)
2058-04-01
Enrollment (Estimated)
100,000
Study Type
Observational
Status
Recruiting
Keywords
Cardiovascular Disease
Cardiac Magnetic Resonance
Myocardial Fibrosis
Valvular Heart Disease
Ischemic Heart Disease
Cardiomyopathy
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Cardiovascular Magnetic Resonance
All patients who present to the Houston Methodist CMR Laboratory
Cardiovascular Magnetic Resonance
Patients will undergo various CMR techniques designed to assess cardiovascular structure and function, tissue characteristics, and flow.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Mortality
All-cause mortality, Cardiovascular mortality (acute Myocardial Infarction, sudden death, heart failure, cerebrovascular, procedural), and Non-cardiovascular mortality
Through study completion, an average of once a year, up to 20 years
Heart Failure
Congestive heart failure
Through study completion, an average of once a year, up to 20 years
Heart and/or Lung Transplantation
Through study completion, an average of once a year, up to 20 years
Left Ventricular and/or Right Ventricular Assist Device Implantation
Through study completion, an average of once a year, up to 20 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Cardiac Interventions
Implantable cardioverter-defibrillator (ICD), pacemakers, cardiac resynchronization therapy, coronary revascularization, valvular intervention, shunt closure
Through study completion, an average of once a year, up to 20 years
Arrhythmic
Sustained ventricular tachycardia, ventricular fibrillation, nonfatal cardiac arrest, appropriate ICD therapy
Through study completion, an average of once a year
Acute myocardial infarction
Through study completion, an average of once a year, up to 20 years
Acute Cerebrovascular Accident
Through study completion, an average of once a year, up to 20 years
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • All patients presenting to the Houston Methodist CMR Laboratory with known or suspected cardiovascular disease.

  • Unable to provide informed consent
Dipan Shah logoDipan Shah
Study Responsible Party
Dipan Shah, Sponsor-Investigator, Director of Cardiovascular Imaging, The Methodist Hospital Research Institute
Study Central Contact
Contact: Rachel Kronman-Gross, BS, 7134416539, [email protected]
Contact: Mohamad Ghosn, PhD, 7134419837, [email protected]
1 Study Locations in 1 Countries

Texas

Houston Methodist Hospital, Houston, Texas, 77030, United States
Rachel Kronman-Gross, BS, Contact, 713-441-6539, [email protected]
Mohamad Ghosn, PhD, Contact, 7134419837, [email protected]
Dipan Shah, MD, Principal Investigator
Recruiting