Non-invasive Coronary Thrombus Imaging to Define the Cause of Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary endpoint will be the degree and location of platelet activation as determined by the target to background ratio of 18F-GP1
研究概览
简要总结
We now have very sensitive blood tests that can pick up damage to the heart and find patients who have had a heart attack. However, whilst this is welcome, it does not identify what causes the heart attack and can sometimes pick up other conditions that cause a strain on the heart.
The classic cause of a heart attack is when a blood clot forms on fatty deposits within the heart arteries. This leads to treating patients with blood thinning medication, and this is very effective and saves lives. However, many apparent heart attacks are not caused by blood clots and some may be caused by blood clots but pass unrecognised.
In this proposal, we will test an exciting new imaging test that can 'see' from outside the body whether there is a blood clot in the heart arteries. This could provide a major new way of assessing patients to ensure they get the right diagnosis and the right treatment. This could ultimately improve the outcomes of or patients with heart attacks.
We will recruit 80 patients in total who have recently been diagnosed with a heart attack from the cardiology department at the Royal Infirmary of Edinburgh. The research team will review patient's medical records to determine eligibility for the study.
The research study involves participants undertaking the following research procedures and assessments:
- A combined Positron Emission Tomography and Computed Tomography (PET-CT) scan of the heart
- Ultrasound scan of the heart (Echocardiogram)
- MRI scan of the heart
- A blood test - a total of up to four tablespoons (60 mL) of blood will be taken for immediate testing and the remaining blood will be stored for future ethically approved studies
- A follow up questionnaire 6 -12 months following the heart attack
详细描述
1.1 BACKGROUND
1.1.1 Background of coronary artery disease and acute myocardial infarction
Coronary artery disease remains the leading cause of death worldwide, with more than 23 million annual deaths estimated to occur by 2030. The introduction of high-sensitivity cardiac troponin measurement has revolutionised the identification and management of patients presenting with acute chest pain and myocardial infarction. However, elevated cardiac troponin concentrations can result from both ischaemic (myocardial infarction) or non-ischaemic (myocardial injury) causes. Moreover, the further subclassification of myocardial infarction relies on the underlying aetiology of infarction which is often not readily apparent and remains a diagnostic challenge.
1.1.2 Universal definition of myocardial infarction
Acute myocardial infarction is defined as cardiomyocyte injury and necrosis in a clinical setting consistent with acute myocardial ischaemia. The fourth universal definition of myocardial infarction describes five subtypes of acute infarction. Type 1 myocardial infarction is characterised by underlying atherosclerotic plaque disruption (rupture, ulceration, fissuring, erosion, or calcific nodules) resulting in intraluminal thrombosis, distal coronary embolisation and intraplaque haemorrhage that ultimately cause myocyte necrosis. In contrast, type 2 myocardial infarction is classified as an ischaemic myocardial injury secondary to oxygen supply and demand mismatch, and importantly is not a consequence of atherosclerotic plaque rupture and coronary atherothrombosis. However, some causes of type 2 myocardial infarction do involve intracoronary thrombus including coronary thromboembolism and spontaneous coronary artery dissection. Currently, invasive coronary angiography remains the primary modality to identify patients presenting with plaque related disruption and coronary thrombosis, ultimately providing the distinction between type 1 and type 2 myocardial infarction. However, it is not always definitive and only 10-20% of patients presenting with type 2 myocardial infarction undergo further investigations to identify the presence of underlying coronary artery disease or to exclude coronary atherothrombosis. Indeed, we recently demonstrated comprehensive cardiac imaging and coronary angiography that identified two thirds of patients had previously unrecognised underlying coronary artery disease, and this resulted in diagnostic reclassification of many patients. These standard techniques were however unable to determine whether this plaque was implicated in the presentation or simply a bystander finding. A non-invasive imaging technique to reliably detect intracoronary thrombus and facilitate this distinction would therefore be of major clinical value.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Males and females ≥ 18 years of age
- •Clinical presentation of chest pain, ST-segment deviation within a coronary artery territory on the electrocardiogram, raised cardiac troponin and non-obstructive coronary arteries on invasive coronary angiography as per international societal diagnostic criteria
排除标准
- •<18 years of age
- •Takatsubo cardiomyopathy
- •Myocarditis
- •Renal failure (estimated glomerular filtration rate <30 mL/min/1.73 m2)
- •Woman of child-bearing potential who are pregnant or breastfeeding
- •Known allergy or contraindication to iodinated contrast or radiotracer
- •Patients unable to tolerate the supine position
- •Patients unable to provide informed consent
研究组 & 干预措施
1
50 patients with myocardial infarction and non-obstructive coronary arteries
干预措施: Hybrid 18F-GP1 positron emission tomography and coronary computed tomography coronary angiography (Radiation)
2
10 patients with suspected coronary thromboembolism 10 patients with suspected spontaneous coronary artery dissection 10 patented with iatrogenic spontaneous coronary artery dissection
干预措施: Hybrid 18F-GP1 positron emission tomography and coronary computed tomography coronary angiography (Radiation)
结局指标
主要结局
The primary endpoint will be the degree and location of platelet activation as determined by the target to background ratio of 18F-GP1
时间窗: 3 years
次要结局
- The secondary endpoints will include measuring the presence of platelet activation in acute myocardial infarction with non-obstructive coronary arteries and identifying the presence and site of platelet activation in thrombosis-related coronary causes of(3 years)
