Cardiovascular DiseasesDEBAKEY-CMRNCT04281823
DeBakey Cardiovascular Magnetic Resonance Study
An observational study of Cardiovascular Diseases, run by Dipan Shah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Cardiovascular Magnetic Resonance
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2008to 1 Apr 2058
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients present to the Houston Methodist CMR Laboratory providing informed consent.
Who may be able to join
- All patients presenting to the Houston Methodist CMR Laboratory with known or suspected cardiovascular disease.
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Rachel Kronman-Gross, BS, 713-441-6539, rkronman-gross@houstonmethodist.org
Mohamad Ghosn, PhD, 7134419837, mghosn@houstonmethodist.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Cardiovascular Magnetic Resonance
- Keywords
- Cardiovascular Disease, Cardiac Magnetic Resonance, Myocardial Fibrosis, Valvular Heart Disease, Ischemic Heart Disease, Cardiomyopathy
- Medical subject headings
- Cardiovascular Diseases, Heart Valve Diseases, Myocardial Ischemia, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Magnetic ResonanceDiagnostic test
Patients will undergo various CMR techniques designed to assess cardiovascular structure and function, tissue characteristics, and flow.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular Magnetic Resonance | All patients who present to the Houston Methodist CMR Laboratory Receives: Diagnostic Test: Cardiovascular Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause mortality, Cardiovascular mortality (acute Myocardial Infarction, sudden death, heart failure, cerebrovascular, procedural), and Non-cardiovascular mortality
Measured: Through study completion, an average of once a year, up to 20 years
Heart Failure
Congestive heart failure
Measured: Through study completion, an average of once a year, up to 20 years
Heart and/or Lung Transplantation
Measured: Through study completion, an average of once a year, up to 20 years
Left Ventricular and/or Right Ventricular Assist Device Implantation
Measured: Through study completion, an average of once a year, up to 20 years
Secondary outcomes (4)
Cardiac Interventions
Implantable cardioverter-defibrillator (ICD), pacemakers, cardiac resynchronization therapy, coronary revascularization, valvular intervention, shunt closure
Measured: 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
Measured: Through study completion, an average of once a year
Acute myocardial infarction
Measured: Through study completion, an average of once a year, up to 20 years
Acute Cerebrovascular Accident
Measured: Through study completion, an average of once a year, up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Apr 2008
- Primary completion1 Apr 2058 (estimated)
- Study completion1 Apr 2058 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Dipan Shah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dipan Shah, The Methodist Hospital Research Institute
- Investigators
- Dipan Shah, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281823
- Sponsor's protocol ID
- Pro00008766
- Acronym
- DEBAKEY-CMR
- Status last verified
- Apr 2026
- First submitted
- 24 Jan 2020
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be made available to other researchers.
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.
PubMed 39745324Tayal 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.
PubMed 38781428Tayal 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.
PubMed 33341417Kitkungvan 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.
PubMed 33341409
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Houston Methodist DeBakey Cardiovascular Magnetic Resonance Study
- ClinicalTrials.gov ID
- NCT04281823
- Acronym / sponsor ID
- DEBAKEY-CMR / Pro00008766
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular Disease, Cardiac Magnetic Resonance, Myocardial Fibrosis, Valvular Heart Disease, Ischemic Heart Disease, Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Dipan ShahUniversity, hospital or other
- Study start
- 1 Apr 2008 (actual)
- Primary completion
- 1 Apr 2058 (estimated)
- Study completion
- 1 Apr 2058 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular Magnetic Resonance | – | Diagnostic Test: Cardiovascular Magnetic ResonanceAll patients who present to the Houston Methodist CMR Laboratory |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients present to the Houston Methodist CMR Laboratory providing informed consent.
Key inclusion criteria (1 listed)
- All patients presenting to the Houston Methodist CMR Laboratory with known or suspected cardiovascular disease.
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular Magnetic ResonancePatients will undergo various CMR techniques designed to assess cardiovascular structure and function, tissue characteristics, and flow. | Diagnostic test | Cardiovascular Magnetic Resonance |
Primary outcome
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
Heart Failure
Time frame: Through study completion, an average of once a year, up to 20 years
Congestive heart failure
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Derived from this study: PubMed 39745324Malahfji 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.
- Derived from this study: PubMed 38781428Tayal 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.
- Derived from this study: PubMed 33341417Tayal 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.
- Derived from this study: PubMed 33341409Kitkungvan 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.
- Individual participant dataSharing planned: No. Participant data will not be made available to other researchers.
Related trials for Cardiovascular Diseases
Recruiting
Efficacy and Safety of Ischemic Preconditioning Therapy Versus Optimal Medical Therapy in Reducing the Recurrence of Ischemic Events in Symptomatic Moyamoya Disease
Moya Moya Disease, Moyamoya Syndrome
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dipan Shah, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Dipan Shah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Kronman-Gross, BS (7134416539, rkronman-gross@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Through study completion, an average of once a year, up to 20 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04281823, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.