COVID-19COMET-19NCT05841485
COVID-19 Microvascular Evaluation Trial
An observational study of COVID-19 and Coronary Microvascular Dysfunction, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COVID-19, Coronary Microvascular Dysfunction
- What is being tested?
- Assessment of coronary microvascular dysfunction using intracoronary pressure-temperature wire
- How many people
- 102 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jun 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Lithuanian University of Health Sciences
Kaunas, LT-50161
Ali Aldujeli, MD. MSc, 864874874, ali.aldujeli@kaunoklinikos.lt
Ayman Haq
About this study
Official title: A Comparative Analysis of Coronary Microvascular Dysfunction in Stable Angina Patients With and Without Severe COVID-19 History
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.
Read the detailed description
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.
Safety monitoring and adverse event reporting procedures will be in place to ensure patient safety. All adverse events occurring during the study will be recorded and reported to the appropriate institutional review boards and regulatory authorities. Serious adverse events will be reported to the principal investigator within 24 hours of the study team's awareness of the event. The study team will regularly review adverse event data to assess patient safety and make any necessary modifications to the study protocol.
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
- Being tested
- Assessment of coronary microvascular dysfunction using intracoronary pressure-temperature wire
- Keywords
- Coronary Microvascular Dysfunction, Stable angina, COVID-19, Mechanical ventilation, Coronary flow reserve, Index of microvascular resistance
- Medical subject headings
- COVID-19, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of coronary microvascular dysfunction using intracoronary pressure-temperature wireDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Assessment of coronary microvascular dysfunction using intracoronary pressure-temperature wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jun 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Klaipėda University
- Responsible party
- Principal investigator, Ali Aldujeli, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841485
- Sponsor's protocol ID
- LUHSKC- 301
- Acronym
- COMET-19
- Status last verified
- Feb 2024
- First submitted
- 30 Apr 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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. 2026 May 12;112(11):615-623. doi: 10.1136/heartjnl-2025-325769.
PubMed 40866120Aldujeli 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.
PubMed 40483738
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of Coronary Microvascular Dysfunction in Stable Angina Patients With and Without Severe COVID-19 History
- ClinicalTrials.gov ID
- NCT05841485
- Acronym / sponsor ID
- COMET-19 / LUHSKC- 301
- Conditions
- COVID-19, Coronary Microvascular Dysfunction
- Keywords
- Coronary Microvascular Dysfunction, Stable angina, COVID-19, Mechanical ventilation, Coronary flow reserve, Index of microvascular resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Klaipėda University
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Safety monitoring and adverse event reporting procedures will be in place to ensure patient safety. All adverse events occurring during the study will be recorded and reported to the appropriate institutional review boards and regulatory authorities. Serious adverse events will be reported to the principal investigator within 24 hours of the study team's awareness of the event. The study team will regularly review adverse event data to assess patient safety and make any necessary modifications to the study protocol.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stable angina patients with a history of severe COVID-19 infection requiring mechanical ventilation | – | Diagnostic Test: Assessment of coronary microvascular dysfunction using intracoronary pressure-temperature wirePatients 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. |
| Patients with stable angina without a history of COVID-19 (Group B) | – | Diagnostic Test: Assessment of coronary microvascular dysfunction using intracoronary pressure-temperature wirePatients 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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 of informed consent by the participant at any time during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of coronary microvascular dysfunction using intracoronary pressure-temperature wireThe 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). | Diagnostic test | 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 |
Primary outcome
Incidence of coronary microvascular dysfunction
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 40866120Tsai 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. 2026 May 12;112(11):615-623. doi: 10.1136/heartjnl-2025-325769.
- Derived from this study: PubMed 40483738Aldujeli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Coronary Microvascular Dysfunction, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Aldujeli, MD, MSc (+37064874874, ali.aldujeli@kaunoklinikos.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of coronary microvascular dysfunction (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05841485, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.