A Comparative Analysis of Coronary Microvascular Dysfunction in Stable Angina Patients With and Without Severe COVID-19 History
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Incidence of coronary microvascular dysfunction
研究概览
简要总结
The COMET trial is an observational, cross-sectional study aimed at comparing the incidence of coronary microvascular dysfunction (CMD) in patients with stable angina who have a history of severe COVID-19 infection requiring mechanical ventilation (Group A) to those without a history of COVID-19 (Group B). A total of 102 participants will be recruited, with 51 patients in each group.
Data will be collected on participants' demographic information, medical history, and COVID-19 infection history (confirmed by PCR test). CMD measurement will be performed using a pressure-temperature wire to assess the coronary flow reserve and index of microcirculatory resistance. In addition, information on participants' current medications will be gathered. The study will employ statistical analysis tools to compare CMD incidence between the two groups and assess the impact of various factors such as age and sex on CMD incidence. The results of the COMET trial will provide valuable insights into the effects of severe COVID-19 infection on CMD in patients with stable angina.
详细描述
The COMET trial is an observational, cross-sectional study that aims to compare the incidence of coronary microvascular dysfunction (CMD) in patients with stable angina who have a history of severe COVID-19 infection requiring mechanical ventilation (Group A) to those without a history of COVID-19 (Group B). A total of 102 participants will be recruited, with 28 patients in each group.
The study will be conducted at two university hospitals: Seamen's Branch, Department of Cardiology, Klaipeda University Hospital, Klaipeda, Lithuania, and the Hospital of Lithuanian University of Health Sciences Kaunas clinics, Kaunas, Lithuania. The anticipated study duration is 6 months.
CMD measurement will involve assessing coronary flow reserve (CFR), fractional flow reserve (FFR), and index of microvascular resistance (IMR) using the CoroFlow system (Coroventis Research AB, Uppsala, Sweden). After diagnostic coronary angiography is performed and no significant visible lesion is identified, nitroglycerin will be administered through the intracoronary catheter. A calibrated coronary physiology wire (Pressure Wire X; Abbott Vascular, Santa Clara, CA, USA) will be equalized to the guide catheter pressure at the sinus of the aorta and advanced to the distal two-thirds of the left anterior descending artery. Three milliliters of normal saline will be administered through the guiding catheter in triplicates during rest and during maximal hyperemia, which will be induced by injecting intracoronary adenosine.
Data analysis will be performed using appropriate statistical tests, such as the chi-squared test or Fisher's exact test for categorical data and the independent-samples t-test or Mann-Whitney U test for continuous data, as appropriate. Multivariable regression analysis will be used to assess the impact of various factors, such as age and sex, on CMD incidence.
The primary outcome measure for this study will be the incidence of CMD in both groups, as measured by both coronary flow reserve (CFR) and index of microvascular resistance (IMR) using the pressure-temperature wire. A potential secondary outcome measure could be the relationship between CMD severity and the severity of the patients' COVID-19 infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of stable angina, consulted by a cardiovascular consultant and referred to undergo diagnostic coronary angiography.
- •Patients who are able to provide informed consent.
- •For Group A: Patients with a history of severe COVID-19 infection requiring mechanical ventilation, confirmed by a PCR test.
- •For Group B: Patients without a history of COVID-19 infection.
排除标准
- •Patients with unstable angina or acute coronary syndrome.
- •Patients with a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft surgery.
- •Patients with known structural heart disease or valvular heart disease.
- •Patients who are unable to undergo intracoronary pressure-temperature wire measurement of CMD due to contraindications or other medical reasons.
- •Withdrawal Criteria:
- •Withdrawal of informed consent by the participant at any time during the study.
- •Development of an unstable medical condition or complication that prevents the participant from completing the study or makes it unsafe for them to continue.
- •Identification of exclusion criteria after enrollment that should have precluded the participant's inclusion in the study.
- •Non-compliance with study procedures or protocol deviations that may affect the validity of the study results.
结局指标
主要结局
Incidence of coronary microvascular dysfunction
时间窗: up to 1 month
Incidence of coronary microvascular dysfunction in both groups, as measured by both coronary flow reserve (CFR) and index of microvascular resistance (IMR) using the pressure-temperature wire.
次要结局
未报告次要终点
研究者
Ali Aldujeli
Cardiovascular disease consultant
Lithuanian University of Health Sciences