Trans-coronary Cooling and Dilution for Cardioprotection During Revascularisation for ST-elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility (Number of studies where all the planned measurements have been collected / total studies)
研究概览
简要总结
A heart attack (myocardial infarction) occurs when an artery supplying blood to the heart is suddenly blocked resulting in damage to the heart muscle.
Patients presenting to hospital with a heart attack undergo an immediate angiogram (x-ray of the arteries in the heart) and are usually treated immediately with a balloon and stent to open their blocked artery. This procedure is called "primary percutaneous coronary intervention" (or primary PCI for short).
An angiogram is a routine procedure that involves insertion of fine plastic tube (catheter) into either the groin or wrist under local anaesthetic. The tube is passed into the artery in the heart and X-ray pictures are taken to find out if the arteries are blocked. Blocked arteries can usually be opened by passing a small balloon into the artery, via the fine plastic tube followed by placement of a stent (a fine metal coil) into the artery to prevent it from blocking again.
Although this treatment is very successful, it can result in damage to the heart muscle when the artery is opened. Cooling the entire body has been shown to reduce heart muscle damage during heart attacks in some patients but not in others; however, it is uncomfortable due to the shivering, expensive and can result in delays in opening the blocked artery.
The investigators are conducting a series of research studies to find out if cooling the heart muscle directly through the catheter being used for the normal primary angioplasty treatment using room temperature may be effective in preserving heart muscle, without the shortcomings of entire body cooling.
The investigators have already published an initial series of ten cases in which this treatment appeared to be feasible without causing significant clinical problems.
The present study is a pilot study designed to assess the rate of patient recruitment and feasibility of this new treatment while exploring some detailed outcomes measuring the restoration of blood flow within the coronary artery at the end of the procedure.
Ultimately if the present pilot study is successful, the investigators plan to go on to undertake a much larger randomised outcome study to determine definitively whether this treatment can help reduce heart attack size.
详细描述
The study population will comprise 60 patients with ST-Elevation Myocardial Infarction (STEMI) presenting to Harefield Hospital undergoing primary percutaneous coronary intervention (PCI).
The primary aim of this pilot trial is to investigate the recruitment rate feasibility and safety of undertaking a randomised trial of simple intracoronary coronary cooling and dilution through the guiding catheter during primary PCI for STEMI to reduce myocardial infarction size.
The secondary aims are as follows:
- The study will explore the invasive haemodynamic assessment of coronary flow and microvascular function
- The study will explore blood biomarkers before and after treatment for myocardial infarction
- The study will explore myocardial salvage after treatment for myocardial infarction with magnetic resonance imaging (MRI) and subsequent final infarct size.
Patients will be randomised 1:1 in the catheterisation lab when coronary angiography has demonstrated a target lesion with proposed primary PCI. Patients randomised to the intervention will receive transcatheter cooling and dilution in addition to usual clinical care. Patients randomised to control will receive usual care alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical ST-elevation myocardial infarction or equivalent (e.g. new onset LBBB)
- •<12 Hrs after symptom onset
- •Thrombolysis in myocardial infarction (TIMI) 0-1 coronary flow in a target vessel
排除标准
- •History of severe asthma
- •Pregnancy
- •Severe concomitant disease or conditions with a life expectancy of less than one year.
结局指标
主要结局
Feasibility (Number of studies where all the planned measurements have been collected / total studies)
时间窗: 1 year
Number of studies where all the planned measurements have been collected / total studies
Safety (Adverse events should not be significantly higher in the treatment arm compared to control, nor plausibly caused by the treatment)
时间窗: 1 year
Adverse events should not be significantly higher in the treatment arm compared to control, nor plausibly caused by the treatment as assessed by CTCAE v5.0
Recruitment rate
时间窗: 1 year
Patients recruited per month
次要结局
- Index of microvascular resistance (IMR) 10 mins after completion of percutaneous coronary intervention and study infusion(1 hour)
- Fractional flow reserve (FFR) 10 mins after completion of percutaneous coronary intervention and study infusion(1 hour)
- Coronary flow reserve (CFR) 10 mins after completion of percutaneous coronary intervention and study infusion(1 hour)
- Resistive reserve ratio (RRR) 10 mins after completion of percutaneous coronary intervention and study infusion(1 hour)
- Resting full-cycle ratio (RFR) 10 mins after completion of percutaneous coronary intervention and study infusion(1 hour)
- Intracoronary temperature change(1 hour)
- Infusion volume(1 hour)
- Infusion rate(1 hour)
- Chest pain during study infusion(1 hour)
- ECG changes during study infusion(1 hour)
- Heart rhythm changes during study infusion(1 hour)
- Myocardial blush grade 10 mins after completion of percutaneous coronary intervention and study infusion(1 hour)
- Thrombolysis in Myocardial Infarction (TIMI) flow 10 mins after completion of percutaneous coronary intervention and study infusion(1 hour)
- ST segment resolution 10 mins after completion of percutaneous coronary intervention and study infusion(1 hour)
- Heart Rhythm disturbance from baseline to 12 hours(12 hours)
- Haemodynamic compromise from baseline to 12 hours(12 hours)
- Left ventricular ejection fraction (LVEF) at 48 hours(2 days)
- Left ventricular ejection fraction (LVEF) at 6 months(6 months)
- Wall motion score index (WMSI) at 48 hours(48 hours)
- Wall motion score index (WMSI) at 6 months(6 months)
- Global longitudinal strain (GLS) at 48 hours(48 hours)
- Global longitudinal strain (GLS) at 6 months(6 months)
- Length of stay(3-5 days)
- Peak high-sensitivity cardiac troponin T (hs-cTnT, ng/l)(1-3 days)
- N-terminal pro-brain natriuretic peptide (NT-proBNP, ng/l)(1-3 days)
- Interleukin-1b(1 day)
- Interleukin-1 receptor antagonist(1 day)
- Interleukin-6(1 day)
- Interleukin-10(1 day)
- First pass microvascular obstruction extent (FP MVO)(1-3 days)
- First pass microvascular obstruction extent (FP MVO) at 6 months(6 months)
- Early MVO extent (% of LV) on 1 min post-gadolinium contrast enhanced MRI, adjusted for area at-risk(1-3 days)
- Early MVO extent (% of LV) on 1 min post-gadolinium contrast enhanced MRI, adjusted for area at-risk, at 6 months(6 months)
- Late MVO (presence / absence) on LGE(1-3 days)
- Late MVO (presence / absence) on LGE at 6 months(6 months)
- Initial infarct size (LGE)(1-3 days)
- Infarct size (LGE) at 6 months(6 months)
- Initial MSI (area-at-risk minus initial infarct size/area-at-risk)(1-3 days)
- MSI (area-at-risk minus initial infarct size/area-at-risk) at 6 months(6 months)
- Left ventricular end-diastolic volume index (LVEDVI)(1-3 days)
- Left ventricular end-diastolic volume index (LVEDVI) at 6 months(6 months)
- Left ventricular end-systolic volume index (LVESVI)(1-3 days)
- Left ventricular end-systolic volume index (LVESVI) at 6 months(6 months)
- Cardiac Magnetic Resonance-based Left ventricular ejection fraction (LVEF)(1-3 days)
- Cardiac Magnetic Resonance-based Left ventricular ejection fraction (LVEF) at 6 months(6 months)
- Myocardial haemorrhage (presence/absence)(1-3 days)
- Myocardial haemorrhage (presence/absence) at 6 months(6 months)
- Myocardial haemorrhage extent (% of LV)(1-3 days)
- Myocardial haemorrhage extent (% of LV) at 6 months(6 months)
- Composite of all-cause mortality and hospitalization for heart failure at 6 weeks(6 weeks)
- Hospitalization for heart failure at 6 weeks(6 weeks)
- Cardiovascular mortality at 6 weeks(6 weeks)
- All-cause mortality at 6 weeks(6 weeks)
- Hospitalization for heart failure at 6 months(6 months)
- Cardiovascular mortality at 6 months(6 months)
- Composite of all-cause mortality and hospitalization for heart failure at 6 months(6 months)
- All-cause mortality at 6 months(6 months)
- Composite of all-cause mortality and hospitalization for heart failure at 12 months(12 months)
- Hospitalization for heart failure at 12 months(12 months)
- Cardiovascular mortality at 12 months(12 months)