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临床试验/NCT02806193
NCT02806193Unknown不适用

Global Cardiovascular Magnetic Resonance Registry

Society for Cardiovascular Magnetic Resonance0 个研究点目标入组 80,000 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80,000
主要终点
Acute myocardial infarction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
— 至 89 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cardiovascular disease, underwent CMR, CT, or ECG

排除标准

  • Patients who are 90 years and older

结局指标

主要结局

Acute myocardial infarction

时间窗: Through study completion, for each year

Heart Failure

时间窗: Through study completion, for each year

heart failure development or worsening of heart failure

Mortality

时间窗: Mortality will be tracked through study completion, for each year

death from various causes including cardiovascular death

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

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