Heart Attack Research Program- Imaging Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
- 试验地点
- 19
- 主要终点
- Proportion of patients with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis)
研究概览
简要总结
The HARP study is a multi-center, diagnostic observational study employing standardized imaging protocols in patients with MINOCA (MI with Non Obstructive Coronary Arteries) to determine the underlying diagnosis in each participant. Participants will be followed for recurrent clinical events, every 6 months, for a maximum of 10 years.
详细描述
HARP is a multi-center, observational study which enrolls men and women with MI who are referred for cardiac catheterization. Eligible participants with MINOCA (defined as no stenosis of >50% in any major epicardial vessel) will undergo optical coherence tomography (OCT) at the time of diagnostic angiography and cardiac magnetic resonance imaging (CMR).
Participants will also have the option to enroll in the HARP-Platelet Sub-Study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic symptoms compatible with diagnosis of MI, such as chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms
- •Objective evidence of MI (either or both of the following):
- •Elevation of troponin to above the laboratory upper limit of normal
- •ST segment elevation of ≥1mm on 2 contiguous ECG leads
- •Willing to provide informed consent and comply with all aspects of the protocol
- •Age ≥ 21 years
排除标准
- •Stenosis ≥50% of any major epicardial vessel on invasive angiography, as determined by the angiographer at the time of clinically ordered cardiac catheterization
- •History of known obstructive coronary artery disease at angiography, including history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- •Recent use of vasospastic agents, such as cocaine, triptans, or ergot alkaloids (≤1 month)
- •Alternate explanation for troponin elevation, such as hypertensive urgency, acute exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary embolism, cardiac trauma
- •Coronary dissection apparent on angiography
- •Excessive coronary tortuosity which, in the angiographer's opinion, increases the risks of OCT
- •eGFR<45 or contraindication to additional contrast needed for OCT in the opinion of the angiographer or treating physician
- •Contraindication to MRI (including but not limited to ferromagnetic implants)
- •Pregnancy
- •Thrombolytic therapy for STEMI (qualifying event)
研究组 & 干预措施
MINOCA
OCT and CMR imaging
干预措施: OCT (Device)
MI-CAD
Screen failures with MI found to have obstructive CAD. Limited data collection for comparison to MINOCA cohort.
干预措施: CMR (Other)
结局指标
主要结局
Proportion of patients with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis)
时间窗: 1 week
次要结局
- Proportion of patients with MINOCA who have spontaneous coronary dissection.(1 week)
- Proportion of patients for whom an etiology can be clearly identified after combining OCT and CMR.(1 week)
- Proportion of patients with MINOCA who have late gadolinium enhancement and/or myocardial edema(1 week)
- Correlation of the presence and location of myocardial abnormalities on CMR with presence and location of plaque disruption on OCT among women with MINOCA.(1 week)
- Area under curve of clinical prediction model for plaque disruption on OCT in patients with MINOCA.(1 week)