COVID-19 Microvascular Evaluation Trial

NCT05841485 | Recruiting

• 1 other identifier: LUHSKC- 301
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Coronary Microvascular Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of coronary microvascular dysfunction

  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.

  up to 1 month

Study Arms (2)

Stable angina patients with a history of severe COVID-19 infection requiring mechanical ventilation

Patients with a history of severe COVID-19 infection (confirmed by a polymerase chain reaction test) requiring mechanical ventilation. This group includes patients who have been recently diagnosed with stable angina and have previously experienced a severe COVID-19 infection that necessitated mechanical ventilation support during their illness.

Diagnostic Test: Assessment of coronary microvascular dysfunction using intracoronary pressure-temperature wire

Patients with stable angina without a history of COVID-19 (Group B)

Patients without a history of COVID-19. This group consists of patients who have been diagnosed with stable angina but have no history of COVID-19 infection. This group serves as a comparison group to assess the potential impact of severe COVID-19 infection on coronary microvascular dysfunction in patients with stable angina.

Diagnostic Test: Assessment of coronary microvascular dysfunction using intracoronary pressure-temperature wire

Interventions

Assessment of coronary microvascular dysfunction using intracoronary pressure-temperature wire DIAGNOSTIC_TEST

The primary assessment method in this study is the measurement of coronary microvascular dysfunction using a pressure-temperature wire to determine coronary flow reserve (CFR) and index of microvascular resistance (IMR).

Patients with stable angina without a history of COVID-19 (Group B); Stable angina patients with a history of severe COVID-19 infection requiring mechanical ventilation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population for the COMET trial consists of adult patients (aged 40 -80 years) with a clinical diagnosis of stable angina. The study population will be divided into two groups: Group A: Patients with a history of severe COVID-19 infection requiring mechanical ventilation, confirmed by a polymerase chain reaction test. This group represents individuals with stable angina who have experienced a severe COVID-19 infection and later on developed stable angina symptoms. Group B: Patients without a history of COVID-19 infection. This group serves as a comparison group to assess the potential differences in CMD incidence among patients with stable angina who have not been affected by COVID-19 infection.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Non-compliance with study procedures or protocol deviations that may affect the validity of the study results.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Klaipėda University: collaborator

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, LT-50161, Lithuania

RECRUITING

Related Publications (2)

• Tsai TY, Aldujeli A, Haq A, Murphy P, Unikas R, Zaliaduonyte-Peksiene D, Braukyliene R, Kiernan TJ, Revaiah PC, Miyashita K, Tobe A, Oshima A, Celeutkiene J, Sharif F, Garg S, Tatarunas V, Onuma Y, Serruys PW. Diagnostic performance of exercise stress testing findings and coronary microvascular dysfunction in patients with angina with non-obstructive coronary artery disease. Heart. 2025 Aug 27:heartjnl-2025-325769. doi: 10.1136/heartjnl-2025-325769. Online ahead of print.

  PMID: 40866120 DERIVED

• Aldujeli A, Tsai TY, Haq A, Puipaite K, Braukyliene R, Tatarunas V, Zaliaduonyte D, Unikas R, Renkens M, Revaiah PC, Miyashita K, Tobe A, Oshima A, Sharif F, Lesauskaite V, Spertus JA, Garg S, Onuma Y, Brilakis ES, Serruys PW. Impact of severe COVID-19 infection on coronary microvascular dysfunction in ANOCA patients: A cross-sectional study. Atherosclerosis. 2025 Aug;407:120389. doi: 10.1016/j.atherosclerosis.2025.120389. Epub 2025 Jun 2.

  PMID: 40483738 DERIVED

MeSH Terms

Conditions

COVID-19; Angina, Stable

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ali Aldujeli, MD, MSc

CONTACT

+37064874874; ali.aldujeli@kaunoklinikos.lt

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiovascular disease consultant

Study Record Dates

• First Submitted: April 30, 2023
• First Posted: May 3, 2023
• Study Start: June 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

LI (1)