Global CMR Registry (GCMR)
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|ClinicalTrials.gov Identifier: NCT02806193|
Recruitment Status : Active, not recruiting
First Posted : June 20, 2016
Last Update Posted : June 20, 2016
|Condition or disease||Intervention/treatment|
|Cardiovascular Diseases||Procedure: Cardiovascular Magnetic Resonance Imaging|
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:
- Variations in CMR protocols within specific clinical indications
- Variations in CMR post-processing, analysis, and reporting
- Practice adherence to appropriateness criteria and guidelines
- Clinical effectiveness of CMR over a long period of clinical application and/or technological advance
- 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 Type :||Observational|
|Estimated Enrollment :||80000 participants|
|Official Title:||Global Cardiovascular Magnetic Resonance Registry|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2020|
Cardiovascular Magnetic Resonance Imaging
Cardiovascular imaging techniques (other subsidiary techniques such as CT and ECG will also be followed)
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.
- Mortality [ Time Frame: Mortality will be tracked through study completion, for each year ]death from various causes including cardiovascular death
- Heart Failure [ Time Frame: Through study completion, for each year ]heart failure development or worsening of heart failure
- Acute myocardial infarction [ Time Frame: Through study completion, for each year ]
- Cardiac Intervention (Implantable cardioverter-defibrillator or ICD) [ Time Frame: Through study completion, for each year ]
- Cardiac Intervention (pacemakers) [ Time Frame: Through study completion, for each year ]
- Cardiac Intervention (cardiac surgery) [ Time Frame: Through study completion, for each year ]
- Cardiac Intervention (coronary revascularization) [ Time Frame: Through study completion, for each year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806193
|Study Chair:||Raymond Y. Kwong, MD, MPH||Brigham and Women's Hospital|