DeBakey Cardiovascular Magnetic Resonance Study (DEBAKEY-CMR)

February 19, 2020 updated by: Dipan Shah

Houston Methodist DeBakey Cardiovascular Magnetic Resonance Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients present to the Houston Methodist CMR Laboratory providing informed consent.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiovascular Magnetic Resonance
All patients who present to the Houston Methodist CMR Laboratory
Diagnostic test: Cardiovascular Magnetic Resonance
Patients will undergo various CMR techniques designed to assess cardiovascular structure and function, tissue characteristics, and flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Through study completion, an average of once a year, up to 20 years
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
Time Frame: Through study completion, an average of once a year, up to 20 years
Congestive heart failure
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
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
Through study completion, an average of once a year, up to 20 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Interventions
Time Frame: Through study completion, an average of once a year, up to 20 years
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
Time Frame: Through study completion, an average of once a year
Sustained ventricular tachycardia, ventricular fibrillation, nonfatal cardiac arrest, appropriate ICD therapy
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
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
Through study completion, an average of once a year, up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dipan Shah

Investigators

  • Principal Investigator: Dipan Shah, MD, The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2008

Primary Completion (Anticipated)

April 1, 2058

Study Completion (Anticipated)

April 1, 2058

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 24, 2020

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00008766

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Participant data will not be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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