Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Index of Microcirculatory Resistance
研究概览
简要总结
The OxAMI-PICSO is a study about the use of pressure controlled intermittent coronary sinus occlusion (PICSO) to improve the treatment of patients presenting with heart attack. PICSO is a device consisting of a balloon which is deployed in the coronary sinus. When inflated the balloon can improve the blood flow to the region of heart affected by the heart attack. The study aims to analyse the potential benefit of PICSO in improving blood flow to heart muscle in a selected group of patients admitted with a large heart attack involving the anterior wall of the heart. The comparator group will be a well-matched group of participants of the ongoing OxAMI study.
In order to select patients with a large heart attack, we will measure the index of microcirculatory resistance (IMR), before completion of the heart attack treatment procedure. The IMR value provides measurement of the blood flow at the level of the tiny vessels branching from the large coronary arteries. Our preliminary data from the OxAMI study have shown that an IMR > 40 suggests that the patient is having a large myocardial infarction (heart attack). Only patients with starting IMR > 40 will be considered eligible for the PICSO treatment.
The benefit of PICSO will be assessed by measuring 1) indexes of coronary blood flow, 2) the extension of the infarcted area and 3) the levels of different molecules released in the blood.
详细描述
The OxAMI-PICSO study is a prospective single centre observational cohort study of the use of pressure-control intermittent coronary sinus occlusion (PICSO) in patients presenting for primary percutaneous coronary intervention (PCI) for acute myocardial infarction.
Patients, age 30-90, presenting with ST elevation myocardial infarction will be considered for inclusion in the study. Measurement of index of microcirculatory resistance (IMR) before stenting is an essential prerequisite for the study: only patients with pre-stenting IMR > 40 will be considered eligible for the PICSO treatment. Patients with IMR≤ 40 will remain in the study but will not undergo PICSO treatment.
The procedure for consent in patients undergoing emergency PCI will be as already established in the ongoing OxAMI study (Ethics Ref 11/SC/0397) Because of the urgency of the situation it is not feasible to obtain fully informed written consent. Fully informed consent requires that the potential participant have time to read and reflect on a patient information sheet which in this context is clinically inadvisable. We therefore propose to obtain verbal assent so as to optimize the amount of appropriate information conveyed to potential participants acutely and minimize the clinical risks involved with substantial delay. The research study will be discussed verbally with the patient and the risks and benefits explained. Only conscious patients, able to provide verbal assent will be enrolled in the study.
In detail the patient at the time of verbal assent process will be informed that as part of the research project he/she might undergo to measurement of the index of microcirculatory resistance (IMR) which allows to have an indirect assessment of the entity of the ongoing heart attack. The patient will be also informed that in case IMR value will be greater than 40, thus suggesting a possible significant damage to the heart muscle that may benefit from additional treatment, he/she might be asked to provide assent for PICSO treatment. Patients with pre-stenting IMR ≤ 40 or those with pre-stenting IMR > 40 who elect not to receive PICSO treatment will be given the opportunity to continue to participate within the OxAMI-PICSO study, but without the use of the PICSO device.
Participants will be reminded that they have the right to withdraw from the study at any stage and that this will not affect their treatment or human rights. Once the emergency phase is over and treatment has been delivered, full written informed consent will be sought as soon as practical. For most patients this means within 12 hours of admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, aged 30 to 90 years,
- •Clinical presentation with STEMI
- •Referred for coronary angiography with view to proceed to PCI with stenting.
排除标准
- •Patients in whom safety or clinical concerns preclude participation.
- •Known anaemia (Hb <9).
- •Pregnant or breast feeding females.
- •Revascularization by mean of balloon angioplasty without stenting
- •History of stroke, TIA or reversible ischemic neurological disease within last 6 months
- •Known severe renal failure (eGFR < 30 ml/min/1.73m2) or history of dialysis or renal transplant
- •Previous coronary bypass artery grafting
- •Known severe valvular abnormalities
- •Previous STEMI presentation
- •Presentation with cardiogenic shock
- •Severe bradycardia (Heart rate < 50 beats per minutes)
- •STEMI due to stent thrombosis
- •Unconscious on presentation
- •Non-cardiac comorbidities and life expectancy < 1 year
- •Use of warfarin
- •Presence of pacemaker or other electrodes in the coronary sinus
- •Contraindications to adenosine
- •Additional exclusion criteria for participants undergoing CMR
- •claustrophobia which limits / prevents participants from remaining in CMR scanner.
- •patients who cannot lie flat on the scan table.
- •patients with metallic implants, pacemakers, implantable defibrillators etc, unless known to be CMR compatible.
- •patients with known allergy to medium of contrast (gadolinium)
结局指标
主要结局
Index of Microcirculatory Resistance
时间窗: 48 hours post primary percutaneous coronary intervention
Assessment of coronary microvascular status using IMR IMR is calculated as the product of distal coronary pressure and transit time of bolus of saline during hyperaemic condition. It is a continuous variable that can range from to infinite value. Despite technically it represents a product of pressure in mmHg and time (seconds), by convention it is expressed in Units. A normal IMR value is accepted to be \< 25 U, however in STEMI patients (as in the cohort reported in the study) an IMR \> 40 U is associated to worse clinical outcome
次要结局
- Infarct Size(24-48 hours post primary percutaneous coronary intervention)
- Infarct Size 6 Months(6 months post primary percutaneous coronary intervention)
研究者
Adrian Banning
Consultant Cardiologist, Professor of Interventional Cardiology
Oxford University Hospitals NHS Trust