NCT04538924Unknown不适用
Multimodality Study on Etiologic Mechanisms, Myocardial Changes, and Prognosis of Patients With Myocardial Infarction With Non-obstructive Coronary Arteries
Vilnius University Hospital Santaros Klinikos2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Rate of cardiovascular death
研究概览
简要总结
This prospective trial will include 150 patients with myocardial infarction with non-obstructive coronary arteries (MINOCA). A thorough clinical, laboratory and imaging evaluation will be performed by novel biomarkers and modern imaging techniques (heart magnetic resonance imaging and noninvasive testing). Moreover, two different treatment groups will be distinguished. Additionally, a retrospective analysis of patients meeting MINOCA criteria will be performed.
详细描述
Primary goals The primary trial goal is to assess the etiologic mechanisms of myocardial damage in patients with MINOCA as well as to evaluate a variety of therapeutic strategies for these patients.
Secondary goals
- To assess functional and morphological myocardial changes in patients with MINOCA;
- To assess the true prevalence and prognostic relevance of MINOCA (all-cause mortality and MACE);
- To test the effect of conventional acute MI therapies (BB, ACEI, ARB, CCB, statins, anti-platelet agents) on MACE (death and myocardial infarction) and all-cause mortality in patients with MINOCA;
- To test the diagnostic and prognostic role of several biomarkers (sST2, BNP, cTnI, CRP, copeptin, procalcitonin, MR-proADM, galectin-3) in patients with MINOCA;
- To assess the impact of MINOCA with respect to chronic health status, such as persistent angina symptoms, impairment in quality of life, and depression;
- To evaluate systemic microcirculation status and assess its effect on long term outcomes.
- To evaluate hospital mortality and all-cause death within 6 and 12 months follow-up;
- To determine recurrent hospitalizations within 30-days, 6 and 12 months follow-up;
- To assess peak creatine kinase, creatine kinase-MB and troponin levels during hospital stay;
- To determine quality of life at 6 and 12 months assessed using the Euroqol 5D (EQ-5D) questionnaire (www.euroqol.org).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •detection of a rise and/or fall of cardiac troponin(cTn) values with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:
- •symptoms of acute myocardial ischaemia;
- •new ischaemic 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 ischaemic aetiology
- •non-obstructive coronary arteries on angiography:
- •the absence of obstructive coronary artery disease (CAD) on angiography, (i.e. no coronary artery stenosis ≥50%), in any potential infarct-related artery;
- •This includes both patients with:
- •normal or near normal coronary arteries (no stenosis >30%)
- •mild coronary atheromatosis (stenosis >30% but <50%).
- •angiography performed within 24 - 48 hours
- •age >18 years
- •informed consent
排除标准
- •acute kidney failure
- •stage 4-5 chronic kidney disease
- •contraindications for coronary angiography or CMR
- •patients involved in another biomedical trial
- •inability to make a decision to participate in the investigation
结局指标
主要结局
Rate of cardiovascular death
时间窗: 12 months follow-up
Rate of all-cause mortality
时间窗: 12 months follow-up
次要结局
- Rate of hospitalization for MI(12 months follow-up)
- Rate of MACE(12 months follow-up)
研究者
Rokas Šerpytis
Principal Investigator; MD
Vilnius University Hospital Santaros Klinikos
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Evaluation of Novel Risk Factors and Clinical Outcomes of Acute Myocardial InfarctionPercutaneous Coronary InterventionAcute Myocardial InfarctionCoronary Artery DiseaseNCT02641184Zhejiang Provincial People's Hospital3,000
招募中
不适用
Stockholm Myocardial Infarction with Nonobstructive Coronaries Study 3NCT05426408Karolinska Institutet85
Unknown
1 期
Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial InfarctionAcute Myocardial InfarctionNCT00437710Azienda Unita Sanitaria Locale di Piacenza50
招募中
4 期
Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy.Endomyocardial BiopsyCardiomyopathies, SecondaryImmunosuppressionHeart FailureMyocarditisNCT04654988Medical University of Warsaw100
终止
不适用
PREdisposition Genetical in Cardiac Insufficiency = Genetic Predisposition to Heart FailureST Elevation (STEMI) Myocardial Infarction of Other SitesNCT01113268Assistance Publique - Hôpitaux de Paris658