Global CMR Registry

NCT ID: NCT02806193

Last Updated: 2016-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31

Brief Summary

The Global CMR Registry aims to promote collaboration of CMR sites worldwide in setting imaging and reporting standards, assessing its diagnostic impact on patient care, and determining the cost-effectiveness of CMR imaging. It will be the largest collective body of evidence reflecting the current clinical applications in patient care, which healthcare payers and governing bodies alike can depend on when metrics such as testing appropriateness, common indications, and diagnostic effectiveness are called for. It will also be able to reflect any changes in patient impact from CMR over time as technical development evolves. Furthermore, it will allow an assessment of improvements in diagnostic and therapeutic thinking, risk stratification, and cost-effectiveness relevant to current patient management.

Detailed Description

A global CMR registry can be a crucial infrastructure of our CMR community that has many benefits. First, it is the largest collective body of evidence reflecting the current clinical applications in patient care, which healthcare payers and governing bodies alike can depend on when metrics such as testing appropriateness, common indications, and diagnostic effectiveness are needed. Second, it reflects any change in patient impact from CMR over time as technical developments evolve. Third, it allows an assessment for improvement of diagnostic and therapeutic evaluation, risk stratification, and cost-effectiveness analysis relevant to patient management.

Some practical questions that a global CMR registry may be able ot address include:

1. Variations in CMR protocols within specific clinical indications

2. Variations in CMR post-processing, analysis, and reporting

3. Practice adherence to appropriateness criteria and guidelines

4. Clinical effectiveness of CMR over a long period of clinical application and/or technological advance

5. Differences in CMR utility across centers, regions, or countries

The data collection process will be a collective effort on part of specialized health professionals across various CMR sites worldwide. All of the data will be extracted from existing registries and databases. Health professionals in the U.S. and abroad will first upload patient data and images onto the registry/database that they currently use. Then if they choose to, they can transmit relevant patient de-identified data onto the global registry using a user-friendly web interface. CMR sites without a database will be invited to use CMR Cooperative or REDCAP. De-identified data (usually submitted in excel or CSV format) will be harmonized and uploaded to the registry website (www.gcmr-scmr.org), which is a firewall and password-protected database that resides at an IT vendor (Center for Systems Biology at Massachusetts General Hospital) in Boston, Massachusetts. The pooled data will be used for retrospective analysis/research approved by the GCMR steering committee and SCMR.

Conditions

Cardiovascular Diseases

Study Design

• Study Time Perspective: RETROSPECTIVE

Study Groups

Cardiovascular Magnetic Resonance Imaging

Cardiovascular imaging techniques (other subsidiary techniques such as CT and ECG will also be followed)

Cardiovascular Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Cardiac magnetic resonance imaging (CMR) has emerged as both a remarkably powerful diagnostic and prognostic tool for the assessment of cardiovascular disease. The high spatial resolution of CMR and the ability to characterize soft tissue provides the opportunity for unique diagnostic assessment of a myriad of cardiac pathology, including ischemic heart disease (IHD), preoperative assessment, intra- cardiac mass and thrombus, pericardial disease, valvular heart disease, and cardiomyopathy evaluation.

Between individual CMR programs, GCMR will offer information useful in assessing the differences in protocol, performance, and clinical adaptation by varying geographic regions, institutional environments, and expertise. Such an assessment is critical for uncovering possible reasons for disparities in performance and obtaining opportunities for advancement.

Interventions

Cardiovascular Magnetic Resonance Imaging

Cardiac magnetic resonance imaging (CMR) has emerged as both a remarkably powerful diagnostic and prognostic tool for the assessment of cardiovascular disease. The high spatial resolution of CMR and the ability to characterize soft tissue provides the opportunity for unique diagnostic assessment of a myriad of cardiac pathology, including ischemic heart disease (IHD), preoperative assessment, intra- cardiac mass and thrombus, pericardial disease, valvular heart disease, and cardiomyopathy evaluation.

Between individual CMR programs, GCMR will offer information useful in assessing the differences in protocol, performance, and clinical adaptation by varying geographic regions, institutional environments, and expertise. Such an assessment is critical for uncovering possible reasons for disparities in performance and obtaining opportunities for advancement.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Cardiovascular disease, underwent CMR, CT, or ECG

Exclusion Criteria

• Patients who are 90 years and older

• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Society for Cardiovascular Magnetic Resonance

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond Y. Kwong, MD, MPH

Role: STUDY_CHAIR

Brigham and Women's Hospital

References

Global Cardiovascular Magnetic Resonance Registry (GCMR) Investigators; Kwong RY, Petersen SE, Schulz-Menger J, Arai AE, Bingham SE, Chen Y, Choi YL, Cury RC, Ferreira VM, Flamm SD, Steel K, Bandettini WP, Martin ET, Nallamshetty L, Neubauer S, Raman SV, Schelbert EB, Valeti US, Cao JJ, Reichek N, Young AA, Fexon L, Pivovarov M, Ferrari VA, Simonetti OP. The global cardiovascular magnetic resonance registry (GCMR) of the society for cardiovascular magnetic resonance (SCMR): its goals, rationale, data infrastructure, and current developments. J Cardiovasc Magn Reson. 2017 Jan 20;19(1):23. doi: 10.1186/s12968-016-0321-7.

Reference Type: DERIVED

PMID: 28187739 (View on PubMed)

Other Identifiers

SCMR_GRANT_001

Identifier Type: -

Identifier Source: org_study_id