2024-518724-72-00招募中4 期
PROgnostic value of precision medicine in patients with Myocardial Infarction and non-obStructive coronary artEries: the PROMISE study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS4 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2024年11月26日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 145
- 试验地点
- 4
- 主要终点
- Angina status and quality of life (evaluated using the Seattle Angina Questionnaire [SAQ]) at 1-year follow-up in patients with MINOCA
研究概览
简要总结
To test if a precision-medicine approach with a careful investigation of the MINOCA aetiology and consequent aetiology-based treatment may result in improved quality of life outcomes.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Ability to give informed consent to the study
- •MINOCA diagnosis, defined as: - Acute myocardial infarction (based on Fourth Universal Definition of Myocardial Infarction Criteria): - Evidence of non-obstructive coronary artery disease on angiography (i.e., no coronary artery stenosis >50%) in any major epicardial vessel. - No specific alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, and myocarditis).
排除标准
- •Inability or limited capacity to give informed consent to the study
- •Pregnant and breast-feeding women or patients considering becoming pregnant during the study period will be excluded. For women of childbearing potential, the use of a highly effective contraceptive measure is required in order to be included in the study. “Highly effective contraceptive” is defined in accordance with the recommendations of the Clinical Trial Facilitation Group as a contraceptive measure with a failure rate of less than 1% per year (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf).
- •Alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, valve disease, hypertrophic cardiomyopathy and myocarditis). Also patients presenting with Takotsubo syndrome will be excluded
- •Contraindication to contrast-enhanced CMR, eg, severe renal dysfunction (glomerular filtration rate <30 mL/min), non–CMR-compatible pacemaker or defibrillator
- •Contraindication to drugs administrated: e.g a history of hypersensitivity to drugs administrated or its excipients, significant renal and/or hepatic disease
- •Patients with comorbidities having an expected survival <1-year will be excluded
结局指标
主要结局
Angina status and quality of life (evaluated using the Seattle Angina Questionnaire [SAQ]) at 1-year follow-up in patients with MINOCA
Angina status and quality of life (evaluated using the Seattle Angina Questionnaire [SAQ]) at 1-year follow-up in patients with MINOCA
次要结局
- Rates of major adverse cardiovascular events (MACE; composite of all-cause mortality; re-hospitalization for myocardial infarction, stroke or heart failure; repeated coronary angiography) at 1-year follow-up in MINOCA patients
- Healthcare primary and secondary related-costs (including costs for tests, procedures and outpatient visits or medicines) and socioeconomic burden of MINOCA patients
- Ability of different circulating biomarkers (ET-1, NPY, CRP, sCD40L and miRNA [miR-16, miR-26a, miR-145, miR-222, miR-155-5p, miR-483-5p and miR-451]) as diagnostic biomarker and stratification tool for specific causes of MINOCA
- Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value
研究者
Rocco Antonio Montone
Scientific
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究点 (4)
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