Targeting Investigation and Treatment in Patients With Type 2 Myocardial Infarction (TARGET-Type 2): A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Trial process outcomes: eligibility, approach, consent and randomisation
研究概览
简要总结
Type 2 myocardial infarction (MI) is common and associated with poor clinical outcomes, with as many as one in ten experiencing recurrent MI within one year, and only one in three alive at five years. Recent prospective data demonstrates two-thirds of patients with type 2 MI have underlying coronary artery disease and one-third have left ventricular systolic impairment. Importantly, this is previously unrecognised in over half of all patients, suggesting there may be opportunities to identify and treat these underlying conditions to modify clinical outcomes. The investigators will undertake a pilot randomised controlled trial in which patients will be randomised to standard care or a complex intervention involving detailed cardiology assessment for the likelihood of coronary disease or left ventricular impairment, followed by targeted investigation and treatment where underlying disease is identified. This study will inform the design and delivery of a prospective multi-centre randomised controlled trial powered for clinical outcomes.
详细描述
TARGET-Type 2 is the pilot phase of a prospective, randomised, open label with blinded endpoint evaluation (PROBE) parallel group, event driven, multicentre trial, assessing the impact of a complex intervention in patients hospitalised with type 2 myocardial infarction. Patients will be recruited from the Royal Infirmary of Edinburgh, Edinburgh (tertiary cardiac referral centre) and the Victoria Hospital, Kirkcaldy (district general hospital). The study aims to recruit 60 patients with type 2 myocardial infarction who will be randomised 1:1 to standard care or the complex intervention.
Potential participants will be identified throughout the hospital, including the Emergency Department (ED), Acute Medical Unit (AMU) and all inpatient wards whilst in hospital and using electronic medical records after discharge. Potential participants who are not approached in hospital (e.g., as they attend out of hours or due to the lack of availability of the study team) will be identified using electronic medical records or through referral from the clinical team and contacted by phone by the research team to invite them to take part in the study. The trial will be integrated into routine clinical care at participating sites. A pre-screening log will be kept of patients who meet the inclusion criteria and are subsequently found to be ineligible or not recruited.
Following consent and completion of baseline assessments patients who meet all inclusion/exclusion criteria and are eligible will be randomised into the study, using a web-based computer-generated randomisation process.
Patients will be randomised 1:1 ratio to either standard care or the complex intervention. Randomisation will be stratified based on the presence of 1) known coronary artery disease and 2) known left ventricular systolic dysfunction. Once randomised, a letter will be sent to the participant's General Practitioner (GP) to inform them of their involvement in the study and treatment allocation. Study participants who are randomised to usual care will not have any additional study visits. Those randomised to the complex intervention may be invited for further investigations to guide additional treatment and invited for follow up clinic visits.
Proposed Complex Intervention: A structured management plan for doctors to guide their (a) risk assessment, (b) targeted investigation and (c) secondary preventative therapy delivered after consultation with a cardiologist. All investigations and treatments recommended are established practice in national and international clinical guidelines for patients with coronary artery disease or LV impairment due to type 1 MI.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients with a clinical diagnosis of type 2 myocardial infarction, defined as:
- •i. Symptoms of myocardial ischaemia, or signs of myocardial ischaemia on 12-lead electrocardiogram (≥0.5mm ST segment depression in any two contiguous leads or new regional T wave inversion)
- •ii. A clinically significant change in high-sensitivity cardiac troponin concentration with at least one value above the 99th centile upper reference limit, or a single measurement if considered significantly elevated
- •iii. Documented evidence of myocardial oxygen supply (anaemia, hypoxia, hypotension, bradycardia, tachycardia, arrhythmia) or demand (hypertension, left ventricular hypertrophy, valvular heart disease) imbalance.
排除标准
- •i. Patients under 30 years who are less likely to benefit from cardiac imaging
- •ii. Inability to give informed consent
- •iii. Patients on renal replacement therapy or with eGFR <30ml/min
- •iv. Patients with advanced frailty (based on Clinical Frailty Score ≥7)
- •v. Patients who are pregnant or breast feeding
- •vi. Patients with ST-segment elevation on 12-lead electrocardiogram
- •vii. Patients with a clinical diagnosis of type 1 myocardial infarction
- •viii. Patients who have had diagnostic imaging confirming coronary vasospasm, embolism or spontaneous coronary artery dissection has caused type 2 myocardial infarction
- •ix. Previous randomization into TARGET-Type 2 pilot study
研究组 & 干预措施
Complex intervention
A structured risk assessment for coronary disease or left ventricular impairment and management plan delivered by a cardiologist to guide targeted investigation and treatment. This may include imaging with coronary computed tomography angiography (CCTA), invasive coronary angiography, transthoracic echocardiography or cardiac MRI. Treatments may include antiplatelet and anticoagulant therapy, statin therapy or treatments for heart failure as indicated in line with international guidelines.
干预措施: Coronary computed tomography angiography (Diagnostic Test)
Complex intervention
A structured risk assessment for coronary disease or left ventricular impairment and management plan delivered by a cardiologist to guide targeted investigation and treatment. This may include imaging with coronary computed tomography angiography (CCTA), invasive coronary angiography, transthoracic echocardiography or cardiac MRI. Treatments may include antiplatelet and anticoagulant therapy, statin therapy or treatments for heart failure as indicated in line with international guidelines.
干预措施: Invasive coronary angiography (Diagnostic Test)
Complex intervention
A structured risk assessment for coronary disease or left ventricular impairment and management plan delivered by a cardiologist to guide targeted investigation and treatment. This may include imaging with coronary computed tomography angiography (CCTA), invasive coronary angiography, transthoracic echocardiography or cardiac MRI. Treatments may include antiplatelet and anticoagulant therapy, statin therapy or treatments for heart failure as indicated in line with international guidelines.
干预措施: Transthoracic echocardiography (Diagnostic Test)
Complex intervention
A structured risk assessment for coronary disease or left ventricular impairment and management plan delivered by a cardiologist to guide targeted investigation and treatment. This may include imaging with coronary computed tomography angiography (CCTA), invasive coronary angiography, transthoracic echocardiography or cardiac MRI. Treatments may include antiplatelet and anticoagulant therapy, statin therapy or treatments for heart failure as indicated in line with international guidelines.
干预措施: Cardiac MRI scan (Diagnostic Test)
Complex intervention
A structured risk assessment for coronary disease or left ventricular impairment and management plan delivered by a cardiologist to guide targeted investigation and treatment. This may include imaging with coronary computed tomography angiography (CCTA), invasive coronary angiography, transthoracic echocardiography or cardiac MRI. Treatments may include antiplatelet and anticoagulant therapy, statin therapy or treatments for heart failure as indicated in line with international guidelines.
干预措施: Antiplatelet Drug (Aspirin or Statin) (Drug)
Complex intervention
A structured risk assessment for coronary disease or left ventricular impairment and management plan delivered by a cardiologist to guide targeted investigation and treatment. This may include imaging with coronary computed tomography angiography (CCTA), invasive coronary angiography, transthoracic echocardiography or cardiac MRI. Treatments may include antiplatelet and anticoagulant therapy, statin therapy or treatments for heart failure as indicated in line with international guidelines.
干预措施: Anticoagulants (Apixaban, Edoxaban, Rivaroxoban, Warfarin) (Drug)
Complex intervention
A structured risk assessment for coronary disease or left ventricular impairment and management plan delivered by a cardiologist to guide targeted investigation and treatment. This may include imaging with coronary computed tomography angiography (CCTA), invasive coronary angiography, transthoracic echocardiography or cardiac MRI. Treatments may include antiplatelet and anticoagulant therapy, statin therapy or treatments for heart failure as indicated in line with international guidelines.
干预措施: Guideline directed heart failure therapy (Drug)
Complex intervention
A structured risk assessment for coronary disease or left ventricular impairment and management plan delivered by a cardiologist to guide targeted investigation and treatment. This may include imaging with coronary computed tomography angiography (CCTA), invasive coronary angiography, transthoracic echocardiography or cardiac MRI. Treatments may include antiplatelet and anticoagulant therapy, statin therapy or treatments for heart failure as indicated in line with international guidelines.
干预措施: Statins (Cardiovascular Agents) (Drug)
结局指标
主要结局
Trial process outcomes: eligibility, approach, consent and randomisation
时间窗: 90 days
The proportion of patients who are eligible, approached, consented and randomised
次要结局
- Frequency of investigation and treatment(90 days)
- Adherence to recommended investigation(90 days)
- Recruitment rate(30 days and 90 days)
- Proportion of patients with changes in prescription of secondary prevention therapy(90 days)
- Change in classification of myocardial infarction(90 days)
- Adherence to recommended treatment(90 days)
- Quantity of missing data(Baseline and 90 days)