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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Procedure: Cardiovascular Magnetic Resonance Imaging

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.


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Study Type : Observational
Estimated Enrollment : 80000 participants
Time Perspective: Retrospective
Official Title: Global Cardiovascular Magnetic Resonance Registry
Study Start Date : January 2014
Estimated Primary Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.





Primary Outcome Measures :
  1. Mortality [ Time Frame: Mortality will be tracked through study completion, for each year ]
    death from various causes including cardiovascular death

  2. Heart Failure [ Time Frame: Through study completion, for each year ]
    heart failure development or worsening of heart failure

  3. Acute myocardial infarction [ Time Frame: Through study completion, for each year ]

Secondary Outcome Measures :
  1. Cardiac Intervention (Implantable cardioverter-defibrillator or ICD) [ Time Frame: Through study completion, for each year ]
  2. Cardiac Intervention (pacemakers) [ Time Frame: Through study completion, for each year ]
  3. Cardiac Intervention (cardiac surgery) [ Time Frame: Through study completion, for each year ]
  4. Cardiac Intervention (coronary revascularization) [ Time Frame: Through study completion, for each year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 89 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Cardiovascular disease, underwent CMR, CT, or ECG

Exclusion Criteria:

  • Patients who are 90 years and older

Information from the National Library of Medicine

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


Sponsors and Collaborators
Society for Cardiovascular Magnetic Resonance
Investigators
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Study Chair: Raymond Y. Kwong, MD, MPH Brigham and Women's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Society for Cardiovascular Magnetic Resonance
ClinicalTrials.gov Identifier: NCT02806193     History of Changes
Other Study ID Numbers: SCMR_GRANT_001
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Participating sites will send relevant de-identified to the data management team for harmonization. The aggregate data will be used for retrospective analyses and research. Researchers requesting data access for either grant proposals or sub-studies will be required to submit a proposal to the GCMR steering committee (composed of various experts in the CMR community) for approval.

If approved, data access will be given to the researchers for a specific time period determined by the magnitude of the work involved, and only for the purposes of the grant proposal or sub-study.


Keywords provided by Society for Cardiovascular Magnetic Resonance:
cardiovascular
cardiac
MRI
CMR
CT
ECG
magnetic resonance
imaging

Additional relevant MeSH terms:
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Cardiovascular Diseases