DeBakey Cardiovascular Magnetic Resonance Study

NCT ID: NCT04281823

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-01

Study Completion Date

2058-04-01

Brief Summary

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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

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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

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Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiovascular Magnetic Resonance

All patients who present to the Houston Methodist CMR Laboratory

Cardiovascular Magnetic Resonance

Intervention Type DIAGNOSTIC_TEST

Patients will undergo various CMR techniques designed to assess cardiovascular structure and function, tissue characteristics, and flow.

Interventions

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Cardiovascular Magnetic Resonance

Patients will undergo various CMR techniques designed to assess cardiovascular structure and function, tissue characteristics, and flow.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unable to provide informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dipan Shah

OTHER

Sponsor Role lead

Responsible Party

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Dipan Shah

Director of Cardiovascular Imaging

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dipan Shah, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

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Houston Methodist Hospital

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rachel Kronman-Gross, BS

Role: CONTACT

7134416539

Mohamad Ghosn, PhD

Role: CONTACT

7134419837

Facility Contacts

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Rachel Kronman-Gross, BS

Role: primary

713-441-6539

Mohamad Ghosn, PhD

Role: backup

7134419837

References

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Tayal 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.

Reference Type DERIVED
PMID: 38781428 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33341417 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33341409 (View on PubMed)

Other Identifiers

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Pro00008766

Identifier Type: -

Identifier Source: org_study_id

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