CTRI/2018/01/011150招募中未知
A prospective, multi-centric study to investigate the plaque characteristics and natural history of lesions in the non-culprit vessels in young Indian patients (less than 45 yrs) with ACS undergoing PCI by Optical Coherence Tomography (OCT) imaging - ACS-OCT
Batra Hospital and Medical Research Centre0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Patient is more than or equals to 18 and less than or equals to 45 years of age and going for PCI of the culprit lesion (more than 90 per cent diameter stenosis)
- •At least more than or equals to 1 de novo lesions in a native coronary segment with a visually estimated diameter stenosis between more than or equals to 40 per cent and less than 90 per cent
- •Patient has documented ACS ( unstable angina, NSTEMI or STEMI within the previous 72 hours)
- •Patient demonstrates a left ventricular ejection fraction (LVEF) of more than or equals to 40 per cent as measured prior to enrollment
- •Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect
排除标准
- •The patient has a life expectancy of less than 24 months due to another medical condition
- •Patient exhibits cardiogenic shock (systolic pressure less than 80mm Hg and PCWP more than 20mm Hg or cardiac index less than 1.8 liters per minute per meter square or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure more than 80 mm Hg) for any time within 24 hours prior to index procedure.
- •Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine more than 2.0 mg per dl or 177 μmol per l)
- •Planned cardiac surgery procedure less than or equals to 6 months post-index procedure.
- •Cerebrovascular accident (CVA) including stroke or TIA within previous 3 months
- •Patient has contraindication to Aspirin clopidogrel, prasugrel or ticagrelor
- •Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 6 months post index procedure
- •Patient that in the opinion of the investigator is not clinically appropriate for OCT evaluation
- •Patient in whom the primary culprit lesion requiring PCI have one of the following characteristics â??
- •vessel is moderately or severely calcified, by visual estimate
- •lesion is ostial in location (within 5.0 mm of vessel origin)
- •lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a more than 60 degree bend in the vessel.
- •lesion involves a diseased (more than 50 per cent stenotic) side branch more than 2.0 mm in diameter
- •lesion is located in the left main coronary artery, whether protected or unprotected
- •arterial or saphenous vein graft lesions or lesions distal to a diseased arterial or saphenous vein graft
研究者
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