Global CMR Registry

• Conditions: Cardiovascular Diseases
• Interventions: Procedure: Cardiovascular Magnetic Resonance Imaging

• Registration Number: NCT02806193
• Lead Sponsor: Society for Cardiovascular Magnetic Resonance

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.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2016-06
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-17
• Last Update Submitted: 2016-06-17
• Study First Posted: 2016-06-20
• Last Update Posted: 2016-06-20
• Primary Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80000

Inclusion Criteria

• Cardiovascular disease, underwent CMR, CT, or ECG

Exclusion Criteria

• Patients who are 90 years and older

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiovascular Magnetic Resonance Imaging	Cardiovascular Magnetic Resonance Imaging	Cardiovascular imaging techniques (other subsidiary techniques such as CT and ECG will also be followed)

Primary Outcome Measures

Name	Time	Method
Acute myocardial infarction	Through study completion, for each year
Heart Failure	Through study completion, for each year	heart failure development or worsening of heart failure
Mortality	Mortality will be tracked through study completion, for each year	death from various causes including cardiovascular death

Secondary Outcome Measures

Name	Time	Method
Cardiac Intervention (Implantable cardioverter-defibrillator or ICD)	Through study completion, for each year
Cardiac Intervention (pacemakers)	Through study completion, for each year
Cardiac Intervention (cardiac surgery)	Through study completion, for each year
Cardiac Intervention (coronary revascularization)	Through study completion, for each year