Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05841485 |
| Other study ID # |
LUHSKC- 301 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Lithuanian University of Health Sciences |
| Contact |
Ali Aldujeli, MD, MSc |
| Phone |
+37064874874 |
| Email |
ali.aldujeli[@]kaunoklinikos.lt |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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). 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.
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.
