Trial Outcomes & Findings for Genetic Determinants of the Coronary Microvascular Obstruction in PCI (NCT NCT05355532)
NCT ID: NCT05355532
Last Updated: 2025-09-25
Results Overview
Death during index hospitalization.
Recruitment status
COMPLETED
Target enrollment
80 participants
Primary outcome timeframe
up to 7-15 days after PCI
Results posted on
2025-09-25
Participant Flow
Participant milestones
| Measure |
"CMVO+" (Patients Has Presented CMVO in PCI)
Patients with 1 type MI that has presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
"CMVO-" (Patients Hasn't Presented CMVO in PCI)
Patients with 1 type MI that hasn't presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genetic Determinants of the Coronary Microvascular Obstruction in PCI
Baseline characteristics by cohort
| Measure |
"CMVO+" (Patients Has Presented CMVO in PCI)
n=40 Participants
Patients with 1 type MI that has presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
"CMVO-" (Patients Hasn't Presented CMVO in PCI)
n=40 Participants
Patients with 1 type MI that hasn't presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
65 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 7-15 days after PCIDeath during index hospitalization.
Outcome measures
| Measure |
"CMVO+" (Patients Has Presented CMVO in PCI)
n=40 Participants
Patients with 1 type MI that has presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
"CMVO-" (Patients Hasn't Presented CMVO in PCI)
n=40 Participants
Patients with 1 type MI that hasn't presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
|---|---|---|
|
Hospital Mortality Rate
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 7-10 day after PCIEcho-cardiography, four-chamber projection, Simpson's method.
Outcome measures
| Measure |
"CMVO+" (Patients Has Presented CMVO in PCI)
n=40 Participants
Patients with 1 type MI that has presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
"CMVO-" (Patients Hasn't Presented CMVO in PCI)
n=40 Participants
Patients with 1 type MI that hasn't presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
|---|---|---|
|
Left Ventricle Ejection Fraction
|
47 ejection fraction percent
Interval 38.0 to 51.0
|
50 ejection fraction percent
Interval 43.0 to 53.0
|
SECONDARY outcome
Timeframe: 7-10 day after PCIDistance in meters that a patient can walk in 6 minutes. Based on the test, the class of chronic heart failure according to New York Heart Association (NYHA) classification is determined.
Outcome measures
| Measure |
"CMVO+" (Patients Has Presented CMVO in PCI)
n=40 Participants
Patients with 1 type MI that has presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
"CMVO-" (Patients Hasn't Presented CMVO in PCI)
n=40 Participants
Patients with 1 type MI that hasn't presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
|---|---|---|
|
Six-minute Walk Test
|
395 meters in 6 minutes
Interval 320.0 to 443.0
|
425 meters in 6 minutes
Interval 380.0 to 465.0
|
SECONDARY outcome
Timeframe: 7-10 day after PCILevel of N-terminal pro-brain natriuretic peptide in pg/ml
Outcome measures
| Measure |
"CMVO+" (Patients Has Presented CMVO in PCI)
n=40 Participants
Patients with 1 type MI that has presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
"CMVO-" (Patients Hasn't Presented CMVO in PCI)
n=40 Participants
Patients with 1 type MI that hasn't presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
|---|---|---|
|
N-terminal Pro-brain Natriuretic Peptide
|
1171 pg/ml
Interval 506.0 to 2071.0
|
530 pg/ml
Interval 333.0 to 916.0
|
SECONDARY outcome
Timeframe: up to 7-15 days after PCIVentricular fibrillation during index hospitalization
Outcome measures
| Measure |
"CMVO+" (Patients Has Presented CMVO in PCI)
n=40 Participants
Patients with 1 type MI that has presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
"CMVO-" (Patients Hasn't Presented CMVO in PCI)
n=40 Participants
Patients with 1 type MI that hasn't presented CMVO in emergency PCI.
different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes.
|
|---|---|---|
|
Ventricular Fibrillation
|
0 Participants
|
0 Participants
|
Adverse Events
"CMVO+" (Patients Has Presented CMVO in PCI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
"CMVO-" (Patients Hasn't Presented CMVO in PCI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ilya Pochinka, MD
Privolzhsky Research Medical University
Phone: +79030561932
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place