DeBakey Cardiovascular Magnetic Resonance Study

Cardiovascular Diseases Clinical Trial

— DEBAKEY-CMR  

Official title:

Houston Methodist DeBakey Cardiovascular Magnetic Resonance Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04281823
• Other study ID #: Pro00008766
• Status: Recruiting
• Start date: April 1, 2008
• Est. completion date: April 1, 2058

Study information

• Verified date: February 2020
• Source: The Methodist Hospital System
• Contact: Rachel Kronman-Gross, BS
• Phone: 7134416539
• Email: rkronman-gross[@]houstonmethodist.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: April 1, 2058
• Est. primary completion date: April 1, 2058
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to provide informed consent

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Diagnostic Test:
• Cardiovascular Magnetic Resonance
Patients will undergo various CMR techniques designed to assess cardiovascular structure and function, tissue characteristics, and flow.

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dipan Shah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Heart Failure	Congestive heart failure	Through study completion, an average of once a year, up to 20 years
Primary	Heart and/or Lung Transplantation		Through study completion, an average of once a year, up to 20 years
Primary	Left Ventricular and/or Right Ventricular Assist Device Implantation		Through study completion, an average of once a year, up to 20 years
Secondary	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
Secondary	Arrhythmic	Sustained ventricular tachycardia, ventricular fibrillation, nonfatal cardiac arrest, appropriate ICD therapy	Through study completion, an average of once a year
Secondary	Acute myocardial infarction		Through study completion, an average of once a year, up to 20 years
Secondary	Acute Cerebrovascular Accident		Through study completion, an average of once a year, up to 20 years