Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05841485
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-04-30
Brief Title:
COVID-19 Microvascular Evaluation Trial
Sponsor:
Lithuanian University of Health Sciences
Organization:
Lithuanian University of Health Sciences
Study Overview
Official Title:
A Comparative Analysis of Coronary Microvascular Dysfunction in Stable Angina Patients With and Without Severe COVID-19 History
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMET-19
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
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 Seamens 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 Fishers 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 teams 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
The study will be conducted at two university hospitals Seamens 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 Fishers 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 teams 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None