Global CMR Registry (GCMR)
Global Cardiovascular Magnetic Resonance Registry
研究概览
详细说明
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.
研究类型
注册 (预期的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Cardiovascular disease, underwent CMR, CT, or ECG
Exclusion Criteria:
- Patients who are 90 years and older
学习计划
研究是如何设计的？
设计细节
- 时间观点：追溯
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Cardiovascular Magnetic Resonance Imaging
Cardiovascular imaging techniques (other subsidiary techniques such as CT and ECG will also be followed)
|
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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mortality
大体时间：Mortality will be tracked through study completion, for each year
|
death from various causes including cardiovascular death
|
Mortality will be tracked through study completion, for each year
|
|
Heart Failure
大体时间：Through study completion, for each year
|
heart failure development or worsening of heart failure
|
Through study completion, for each year
|
|
Acute myocardial infarction
大体时间：Through study completion, for each year
|
Through study completion, for each year
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Cardiac Intervention (Implantable cardioverter-defibrillator or ICD)
大体时间：Through study completion, for each year
|
Through study completion, for each year
|
|
Cardiac Intervention (pacemakers)
大体时间：Through study completion, for each year
|
Through study completion, for each year
|
|
Cardiac Intervention (cardiac surgery)
大体时间：Through study completion, for each year
|
Through study completion, for each year
|
|
Cardiac Intervention (coronary revascularization)
大体时间：Through study completion, for each year
|
Through study completion, for each year
|
合作者和调查者
调查人员
- 学习椅：Raymond Y. Kwong, MD, MPH、Brigham and Women's Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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.
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.