Clinical trial NCT02806193: Global CMR Registry
Official title: Global Cardiovascular Magnetic Resonance Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Keywords: cardiovascular
cardiac
MRI
CMR
CT
ECG
magnetic resonance
imaging
Lead sponsor: Society for Cardiovascular Magnetic Resonance
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 80000
Sex: ALL
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The registry data will be collected from patients of various clinical CMR sites that have agreed to contribute their data to the registry.

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.

Eligibility criteria: Inclusion Criteria:

* Cardiovascular disease, underwent CMR, CT, or ECG

Exclusion Criteria:

* Patients who are 90 years and older

Primary outcomes:
measure: Mortality
timeFrame: Mortality will be tracked through study completion, for each year
measure: Heart Failure
timeFrame: Through study completion, for each year
measure: Acute myocardial infarction
timeFrame: Through study completion, for each year
Secondary outcomes:
measure: Cardiac Intervention (Implantable cardioverter-defibrillator or ICD)
timeFrame: Through study completion, for each year
measure: Cardiac Intervention (pacemakers)
timeFrame: Through study completion, for each year
measure: Cardiac Intervention (cardiac surgery)
timeFrame: Through study completion, for each year
measure: Cardiac Intervention (coronary revascularization)
timeFrame: Through study completion, for each year
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Raymond Y. Kwong, MD, MPH
role: STUDY_CHAIR
References:
citation: 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.