Anatomical, Physiological and Inflammatory Characterization of the Non-Culprit Vessels in Patients Undergoing Primary PCI for ST-Elevation Myocardial Infarction in the Presence of Multivessel Disease Toward a Personalised Approach to Complete Revascularisation After Primary PCI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 3
- 主要终点
- Correlation between major adverse cardiac & cerebrovascular events (MACCE) and CTCA-derived anatomical, physiological, plaque & inflammatory characteristics and serum inflammatory markers at 2 years
研究概览
简要总结
Most heart attacks occur because a clot forms in a coronary artery blocking blood flow. Without blood heart muscle dies. Untreated, clots can cause a specific type of heart attack -ST-elevation myocardial infarction (STEMI). STEMI patients are treated immediately by finding the blocked artery ("culprit" lesion) using a dye injected into the coronary arteries and then by unblocking the artery using balloons and stents. This procedure - primary angioplasty - is offered 24/7 and limits the size of heart attacks and saves lives.
Cardiologists know how to treat STEMI patients but it's less clear what to do about narrowings in other coronary arteries ("bystander" disease). This is important - if they're left alone some bystander lesions can cause future events including heart attacks or angina. Recent trials compared stenting ALL the bystander narrowings after primary angioplasty, with stenting none and showed some benefit from stenting all of them ("complete revascularisation").
However, complete revascularisation carries extra risk, putting patients through more complicated procedures and using up resource. A blanket strategy of complete revascularisation of ALL bystander narrowings in ALL STEMI patients is unlikely to be the correct answer as only a small minority of these patients have further events.
In PICNIC the investigators want to identify bystander narrowings most likely to cause a future event, and those unlikely to do so. The study can then test the hypothesis that only the high-risk bystander narrowings need stenting, and the others can be treated with tablets only. Investigators will study patients using specialised imaging techniques from coronary artery CT scans and levels of inflammation to see which narrowings cause future events and which do not. If this can be done, a case can be made to test complete revascularisation only in bystander narrowings that look high risk.
详细描述
Approximately 50% of patients presenting with an acute ST-segment elevation myocardial infarction (STEMI) have multivessel coronary artery disease (CAD). Five randomized studies have shown that complete revascularization, either at the time of primary percutaneous coronary intervention (PPCI) or within 45 days of the index admission, is safe and reduces the risk of repeat coronary revascularization and myocardial infarction (MI), particularly in the non-infarct related artery (NIRA). Despite these improvements in clinical outcomes, no study to date has provided a mechanistic insight as to how complete revascularization of chronic bystander disease may lead to the observed benefit. Indeed, the randomized studies, through the variable nature of their results (reduction in MI versus revascularization etc), have suggested the possibility that there are differing mechanisms for the observed benefit. The data would also be consistent with the concept that not all patients undergoing primary PCI with bystander disease require or benefit from complete revascularisation. This is an important possibility with important potential implications for resource utilisation and patient experience.
The investigators hypothesize that the susceptibility of non-culprit disease to ischaemic events after primary PCI is variable between individuals, and possibly even between their coronary vessels and lesions. Specifically, the investigators postulate that this susceptibility may be related to multiple factors including their anatomical and physiological vulnerability, and their local vascular inflammatory status. In order to test this hypothesis, the investigators will systematically examine the following parameters in each bystander coronary vessel in patients who present with STEMI and are undergoing primary PCI of the culprit vessel:
- markers of systemic inflammatory status
- plaque anatomy including lesion severity and markers of lesion vulnerability on CTCA
- assessment of individual coronary vessel inflammation using CT-derived fat attenuation index
- vessel physiology using FFRCT (fractional flow reserve from computed tomography) incorporating wall shear stress and axial plaque stress.
Aims
The aims of this study are to address the following research questions:
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent (post PPCI)
- •Age 18 years to 85 years
- •Presentation of acute STEMI within 12 hours of symptom on-set
- •Culprit artery PPCI
- •Coronary stenosis of > 50% diameter stenosis by visual estimation in NIRA with a minimum diameter of 2.5mm
排除标准
- •Cardiogenic shock
- •Decompensated heart failure requiring intubation, inotropes, or intra-aortic balloon counter pulsation
- •Refractory ventricular arrhythmia
- •Previous coronary artery bypass surgery (CABG)
- •Stent thrombosis and in stent restenosis
- •An intention before inclusion into the study to revascularize a non-culprit lesion
- •Active malignancy or inflammatory disorders such as rheumatoid arthritis or inflammatory bowel disease
- •Severe valvular heart disease requiring surgery
- •Planned surgical revascularisation
- •Active participation in another study/trial
- •< 12 months life expectancy
- •Contraindication to CTCA
- •Presence of internal defibrillator
- •Known allergy to iodinated contrast
- •Pregnancy
- •Contraindication to intravenous beta blockade
- •Contraindication to acute sublingual nitrate administration
- •Mechanical prosthetic heart valve
- •Advanced renal impairment (creatinine >200)
- •Significant valve disease (sever aortic stenosis or regurgitation; severe mitral regurgitation)
- •Angiographic exclusion criteria
- •NIRA stenosis of 50% or more in the left main stem or the ostia of both the left anterior descending and circumflex arteries
- •< TIMI (thrombolysis in myocardial infarction) flow grade 3 in the NIRA,
- •Evidence of thrombus in the NIRA.
结局指标
主要结局
Correlation between major adverse cardiac & cerebrovascular events (MACCE) and CTCA-derived anatomical, physiological, plaque & inflammatory characteristics and serum inflammatory markers at 2 years
时间窗: 2 years
Correlation between: 1. major adverse cardiac \& cerebrovascular events (MACCE) defined as the composite of all-cause mortality, cardiovascular death, cardiac arrest, acute coronary syndrome (unstable angina, NSTEMI, or STEMI), additional revascularization by CABG or PCI, rehospitalisation for angina, heart failure, stroke, ventricular or atrial fibrillation or tachyarrhythmia at 2 years \&: 2. Anatomical \& physiological characteristics of coronary vessels/lesions in the NIRA(s) as assessed by CTCA parameters (FFRCT + FAI + plaque characteristics)
次要结局
- Correlation between major adverse cardiac & cerebrovascular events (MACCE) and components of CTCA-derived anatomical, physiological, plaque & inflammatory characteristics and serum inflammatory markers at 1 year(1 year)
- Development of a risk score to predict clinical events based upon individual-, vessel- & lesion-specific factors(3 years)
- Correlation between anatomical, physiological & serum inflammatory markers and future adverse events at 3 years(3 years)