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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- plaque disruption
研究概览
简要总结
Coronary artery disease and its manifestations are seen at younger ages, presentation with acute coronary syndromes and with high fatality in Indian patients. Recent investigations have implicated a complex interaction of certain phenotypic characterization of plaque detected on coronary CTA and risk factors for a pro-thrombotic milieu as an important substrate associated with a higher risk of ACS. Lipid rich plaques as seen by OCT evaluation in non-culprit vessels have been reported to be predictors of adverse outcomes. Additional FFR evaluation also can predict higher event rates in patients with abnormal FFR values. There is no published data among CAD patients in India which characterizes coronary plaque morphology and plaque burden with OCT in non- culprit vessels in predicting future events like ACS in young Indian patients undergoing PCI for symptomatic CAD.
Our hypothesis is that young ACS patients with TCFA in non-culprit vessels will have a worse outcome as compared to those without TCFA. In addition, lesions in non-culprit vessels with FFR < 0.80 would be an additional predictor of adverse outcomes during follow up.
Optical coherence tomography (OCT) is emerging as a new gold standard for endovascular imaging of plaque morphology especially identifying vulnerable plaques. The addition of FFR evaluation in these vessels could give incremental information in predicting adverse morbid events like ACS and sudden death on follow up.
The ACS-OCT India will evaluate the plaque characteristics (minimum lumen area, fibrous cap thickness, lipid arc extension, presence of microcalcification macrophages infiltration and microchannel formation at the explored plaques) of non-culprit lesions at baseline & follow-up by OCT analysis and additional FFR. This information will be correlated with the follow clinical data in these patients undergoing PCI for ACS in young Indian patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
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 – 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.
结局指标
主要结局
plaque disruption
时间窗: baseline and 1 year
minimum lumen area, fibrous cap thickness, lipid arc extension, presence of micro-calcification macrophage infiltration and microchannel formation at the explored plaques, spotty calcification and cholesterol crystals
时间窗: baseline and 1 year
Intraluminal abnormalities: Red thrombus, White thrombus, Re-canalized thrombus
时间窗: baseline and 1 year
In the group of stented patients additionally we will look for features of stent mal-apposition, NIH, plaque prolapse and intimal dissection
时间窗: baseline and 1 year
次要结局
- Incidence of MACE, a composite of Cardiac Death, MI or re-hospitalization for progressive angina(30 days, 6, months and 1, 2 and 3 years)