Houston Methodist DeBakey Cardiovascular Magnetic Resonance Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Dipan Shah
- 入组人数
- 100,000
- 试验地点
- 2
- 主要终点
- Heart Failure
研究概览
简要总结
While advancements in cardiac magnetic resonance (CMR) have improved image quality, it is unclear how these improvements are connected to the clinical evaluation of individuals with cardiovascular disease. The aim of this large prospective registry revolves around 4 key principles: 1) utilize CMR to gain additional pathophysiologic insights into cardiovascular disease, 2) understand how CMR compares to alternative cardiovascular diagnostic modalities, 3) determine how CMR affects clinical management decisions, and 4) establish a link between CMR findings and long term prognosis in patients with known or suspected cardiovascular disease. The ultimate aim is to utilize CMR to improve patient outcomes.
CMR techniques to be studies include function, fibrosis, and flow. Focus areas include valvular heart disease, ischemic heart disease, cardiomyopathies, and vascular disease.
详细描述
Patient Population, Recruitment, and Consent:
Patients presenting to the Houston Methodist DeBakey CMR Laboratory will be enrolled from April 2008 to April 2038. It is expected that up to 100,000 patients may be enrolled during this period.
Subjects will be identified based on their referral to the Houston Methodist DeBakey CMR Laboratory for MRI studies during the proposed study period.
After enrollment, a registered nurse or physician will perform a thorough structured patient interview and/or review of electronic health records to document baseline medical history including cardiac risk factors, symptoms, medication usage, and prior procedure history. A small blood sample will be drawn and stored for future biomarker and/or genetic testing analysis. Annual follow up for clinical status will be performed via review of electronic health records; structured telephone interviews with the patients, relatives, and/or their health care providers; and/or the social security death index database.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients presenting to the Houston Methodist CMR Laboratory with known or suspected cardiovascular disease.
排除标准
- •Unable to provide informed consent
研究组 & 干预措施
Cardiovascular Magnetic Resonance
All patients who present to the Houston Methodist CMR Laboratory
干预措施: Cardiovascular Magnetic Resonance (Diagnostic Test)
结局指标
主要结局
Heart Failure
时间窗: Through study completion, an average of once a year, up to 20 years
Congestive heart failure
Left Ventricular and/or Right Ventricular Assist Device Implantation
时间窗: Through study completion, an average of once a year, up to 20 years
Mortality
时间窗: Through study completion, an average of once a year, up to 20 years
All-cause mortality, Cardiovascular mortality (acute Myocardial Infarction, sudden death, heart failure, cerebrovascular, procedural), and Non-cardiovascular mortality
Heart and/or Lung Transplantation
时间窗: Through study completion, an average of once a year, up to 20 years
次要结局
- Arrhythmic(Through study completion, an average of once a year)
- Acute Cerebrovascular Accident(Through study completion, an average of once a year, up to 20 years)
- Acute myocardial infarction(Through study completion, an average of once a year, up to 20 years)
- Cardiac Interventions(Through study completion, an average of once a year, up to 20 years)
研究者
Dipan Shah
Director of Cardiovascular Imaging
The Methodist Hospital Research Institute