DEFINing the PrEvalence and Characteristics of Coronary Artery Disease Among Patients With TYPE 2 Myocardial Infarction Using CT-FFR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Prevalence of hemodynamically significant stenosis
研究概览
简要总结
The primary objectives of this study include:
- determine the prevalence of coronary artery disease among patients with type 2 myocardial infarction
- determine the prevalence of hemodynamically significant stenosis among patients with type 2 myocardial infarction
The investigators hypothesize that patients with type 2 myocardial infarction will have a high burden of coronary artery plaque and a high prevalence of obstructive coronary artery disease with hemodynamic significance.
详细描述
RECRUITMENT
Patients in the Emergency Department or admitted to Massachusetts General Hospital with an elevated high-sensitivity cardiac troponin will be identified daily by the Clinical Core Laboratory at Massachusetts General Hospital. The study investigators will then review the electronic medical record for each of these patients to determine if the cause of the patients' elevated high-sensitivity troponin is a type 2 myocardial infarction. If so, their record will be reviewed to determine if they meet the inclusion criteria for enrollment and to ensure no exclusion criteria are present. Patients with a type 2 MI who are eligible for enrollment, will then be approached during their hospital stay to discuss the study and their interest in consenting and enrolling in our study. Prior to approaching the patient, the responding clinician treating the patient will be contacted to obtain the primary team's approval before approaching the patient. In addition to confirming that the patient is an acceptable candidate for the research, a clinician from the primary team must introduce the study to the patient and obtain the patient's permission prior to being contacted by our study staff. 50 patients will be enrolled.
STUDY PROCEDURES
- Study visits and parameters to be measured (e.g. laboratory tests, x-rays, and other testing) Patients who enroll in the study will undergo a CT coronary angiogram during their index admission. In addition, patients will have the option of providing a blood sample for future research. These biorepository samples may be used in the future for biomarker analysis to examine associations between serum biomarkers of cardiac injury, inflammation, and atherosclerosis, and coronary plaque presence/ severity and for predicting future cardiovascular events up to 1-year. Genetic testing will not be performed on these samples. There will be no required follow-up visits following their index admission.
- Drugs to be used (dose, method, schedule of administration, dose modifications, toxicities).
Patients will receive nitroglycerin prior to their CT coronary angiogram in the form of a transdermal patch (0.8 mg/h [2 x 0.4 mg/h]; Nitro-Dur, Merck & Co. Inc., White-House Station, New Jersey). Nitroglycerin will be administered at least 45 minutes before electrocardiography-gated coronary CTA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Capable of giving informed consent
- •Patients aged greater than18 years diagnosed with type 2 MI, defined based on the 4th Universal Definition of Myocardial Infarction (1), during their index hospitalization
- •Type 2 MI will be defined as detection of a rise and/or fall of troponin levels with at least one value above the 99th percentile and evidence of an imbalance between myocardial oxygen supply and demand, requiring at least one of the following:
- •Symptoms of acute myocardial ischemia;
- •New ischemic ECG changes;
- •Development of pathological Q waves;
- •Imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality in a pattern consistent with an ischemic etiology
- •Patients with medical precipitants of their type 2 MI or post-operative type 2 MI. A minimum of 10 patients with post-operative type 2 MI will be included to ensure a diverse clinical patient population is enrolled.
排除标准
- •Other types of MI
- •Hemodynamic instability
- •eGFR <30 ml/min/1.73m2
- •Pregnant or breast-feeding women
- •Contrast allergy
- •Pre-operative history of MI, coronary angiography or coronary revascularization for patients with post-operative type 2 MI
- •Severe arrhythmias precluding optimal CT image acquisition
- •Prior coronary artery bypass grafting
- •Known prior left main coronary artery PCI
- •Known PCI of the left coronary system combined with >30% stenosis in the left main artery
- •Known prior PCI to 2 or more major coronary vessels (i.e. left anterior descending artery, left circumflex artery, right coronary artery)
- •Allergy or contraindication to nitroglycerin
结局指标
主要结局
Prevalence of hemodynamically significant stenosis
时间窗: 1 year
as determined by FFR \<0.8
Prevalence of obstructive coronary artery disease
时间窗: 1 year
(defined as a stenosis of greater or equal to 70% in any epicardial vessel except left main coronary artery where greater or equal to 50% will be considered obstructive)
次要结局
- Prevalence of non-calcified coronary plaque(1 year)
- Prevalence of calcified coronary plaque(1 year)
- Change in prescription rates for antiplatelet agents, lipid lowering therapy, beta blockers, and ACEi/ARB after CT coronary angiogram(1 year)
- Prevalence of high-risk plaque features(1 year)
- Number of obstructive stenosis in coronary arteries(1 year)
- Prevalence of any coronary plaque(1 year)
研究者
James L. Januzzi
Principal Investigator
Massachusetts General Hospital
