Evaluating heart blood flow issues in COVID-19 patients with stable angina

A Comparative Analysis of Coronary Microvascular Dysfunction in Stable Angina Patients With and Without Severe COVID-19 History

This study is trying to see if people with stable angina who had severe COVID-19 and needed a ventilator have more heart blood flow problems than those who didn't have such a history.

Quick facts

• Study type: Observational
• Enrollment: 102 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Lithuanian University of Health Sciences (Academic / other)
• Locations: 1 site (Kaunas)
• Trial ID: NCT05841485 on ClinicalTrials.gov

What this trial studies

The COMET trial is an observational study that compares the incidence of coronary microvascular dysfunction (CMD) in patients with stable angina who have a history of severe COVID-19 requiring mechanical ventilation to those without such a history. A total of 102 participants will be recruited, with detailed assessments of coronary flow reserve and microcirculatory resistance conducted using specialized pressure-temperature wires. Data on demographics, medical history, and current medications will also be collected to analyze the impact of various factors on CMD incidence. The study aims to provide insights into the cardiovascular effects of severe COVID-19.

Who should consider this trial

Good fit: Ideal candidates include patients with stable angina, specifically those with a history of severe COVID-19 requiring mechanical ventilation or those without such a history.

Not a fit: Patients with unstable angina, acute coronary syndrome, or significant prior heart interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of heart complications in COVID-19 survivors, leading to better management strategies for affected patients.

How similar studies have performed: While there have been studies on cardiovascular effects of COVID-19, this specific comparison of CMD in stable angina patients is novel.

Eligibility criteria

Here's a detailed outline of the eligibility criteria, including inclusion, exclusion, and withdrawal criteria for the COMET trial. Please review and let me know if you need any further clarification or have additional information to provide.

Inclusion Criteria:

1. Patients with a clinical diagnosis of stable angina, consulted by a cardiovascular consultant and referred to undergo diagnostic coronary angiography.
2. Patients who are able to provide informed consent.
3. For Group A: Patients with a history of severe COVID-19 infection requiring mechanical ventilation, confirmed by a PCR test.
4. For Group B: Patients without a history of COVID-19 infection.

Exclusion Criteria:

1. Patients with unstable angina or acute coronary syndrome.
2. Patients with a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft surgery.
3. Patients with known structural heart disease or valvular heart disease.
4. Patients who are unable to undergo intracoronary pressure-temperature wire measurement of CMD due to contraindications or other medical reasons.

Withdrawal Criteria:

1. Withdrawal of informed consent by the participant at any time during the study.
2. Development of an unstable medical condition or complication that prevents the participant from completing the study or makes it unsafe for them to continue.
3. Identification of exclusion criteria after enrollment that should have precluded the participant's inclusion in the study.
4. Non-compliance with study procedures or protocol deviations that may affect the validity of the study results.

Where this trial is running

Kaunas

• Lithuanian University of Health Sciences — Kaunas, Lithuania (Recruiting)

Study contacts

• Study coordinator: Ali Aldujeli, MD, MSc

Conditions COVID-19; Coronary Microvascular Dysfunction; Stable angina; Mechanical ventilation; Coronary flow reserve; Index of microvascular resistance