跳至主要内容
临床试验/NCT04440761
NCT04440761招募中不适用

Barts Myocardial Infarction With Non-Obstructed Coronary Arteries (MINOCA) Registry

Queen Mary University of London1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
1
主要终点
Questionnaire to assess change in symptoms at 2 months post-initial review in clinic/ward

研究概览

简要总结

The last 15 years the introduction of primary angioplasty has radically improved outcomes for acute myocardial infarction (AMI). However, the system wide availability of prompt investigation has revealed an important group of patients where progress has stalled, the diagnosis is unclear and therapeutic approaches are uncertain. Myocardial infarction with non-obstructive coronary arteries (MINOCA) is found in 1 - 13% of all patients with a clinical diagnosis of AMI.

These patients present a therapeutic predicament since coronary revascularization is not appropriate. Guidelines do not exist for their management - yet the condition is not benign - the 12-month prognosis, although better than obstructive coronary artery disease patients is still guarded with recent data suggesting many questions remain unanswered.

详细描述

This study utilises a prospectively collected clinical database. All patients referred to the Interventional Cardiology team are included onto this database. No patients will be contacted solely for research purposes. Patients will not have any investigations/procedures performed for research purposes. All data will only be available for access by named members of the Interventional Cardiology team. Data will be anonymised by the clinical care team and passed onto the research team before it is used and no patient identifiable information will be used in the analysis of the study or the publications of its results.

The database started in April 2015 and has collected data on all patients so far and will continue to do so for the duration of clinical work by the Interventional Cardiology team. As a result this study will continue indefinitely.

This study will include all patients admitted to or reviewed in clinic at Barts Health NHS Trust with either a diagnosis of MINOCA or who do not have a clear cause of a troponin rise. These patients range from young adults to the elderly and will include any patient ≥16 years of age. Patients who are followed up with and without any intervention (i.e. both medically managed patients as well as patients undergoing intervention) are equally as important and therefore the investigators shall include both groups of patients.

Patients will be included from referrals made by other clinicians either as in or outpatients. All these patients have their clinical data captured on a database or hospital based clinical programme.

This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients diagnosed with MINOCA among all patients with coronary artery disease.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both male and female patients ≥16 years of age will be included
  • All patients will have a diagnosis MINOCA. Any patient who does not have a clear cause of troponin rise

排除标准

  • Patients <16 years will not be included in this study.

结局指标

主要结局

Questionnaire to assess change in symptoms at 2 months post-initial review in clinic/ward

时间窗: 2 months

Change in symptoms assessed by Questionnaire

Mortality

时间窗: 1 year

Assessment of mortality

Formal diagnosis made of the cause of troponin rise

时间窗: Baseline

Diagnosis

Timing of diagnosis made of the cause of troponin rise

时间窗: Baseline

Time to first diagnosis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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