Global CMR Registry

Cardiovascular Diseases Clinical Trial

— GCMR  

Official title:

Global Cardiovascular Magnetic Resonance Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02806193
• Other study ID #: SCMR_GRANT_001
• Status: Active, not recruiting
• Phase: N/A
• First received: June 13, 2016
• Last updated: June 17, 2016
• Start date: January 2014

Study information

• Verified date: June 2016
• Source: Society for Cardiovascular Magnetic Resonance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80000
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 89 Years

Eligibility

Inclusion Criteria:

• Cardiovascular disease, underwent CMR, CT, or ECG

Exclusion Criteria:

• Patients who are 90 years and older

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Society for Cardiovascular Magnetic Resonance

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	death from various causes including cardiovascular death	Mortality will be tracked through study completion, for each year	No
Primary	Heart Failure	heart failure development or worsening of heart failure	Through study completion, for each year	No
Primary	Acute myocardial infarction		Through study completion, for each year	No
Secondary	Cardiac Intervention (Implantable cardioverter-defibrillator or ICD)		Through study completion, for each year	No
Secondary	Cardiac Intervention (pacemakers)		Through study completion, for each year	No
Secondary	Cardiac Intervention (cardiac surgery)		Through study completion, for each year	No
Secondary	Cardiac Intervention (coronary revascularization)		Through study completion, for each year	No