N/A
N=80
Genetic Determinants of the Coronary Microvascular Obstruction in PCI
Myocardial Infarction · No-Reflow Phenomenon
Bottom Line
View on ClinicalTrials.gov: NCT05355532 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Hospital Mortality Rate — 6; 2 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- different variants of SNPs that may be associated with the coronary microvascular obstruction development (Genetic)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Privolzhsky Research Medical University
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Mortality Rate |
6; 2 | — |
| SECONDARY Left Ventricle Ejection Fraction |
47; 50 | — |
| SECONDARY Six-minute Walk Test |
395; 425 | — |
| SECONDARY N-terminal Pro-brain Natriuretic Peptide |
1171; 530 | — |
| SECONDARY Ventricular Fibrillation |
0; 0 | — |
Summary
Myocardial infarction (MI) remains one of the most common causes of death. Percutaneous coronary intervention (PCI) is the main treatment option to restore blood flow through the infarction-related coronary artery (IRA) in MI patients. Performing PCI significantly reduces mortality, but in 5-10% cases, PCI is complicated by the development of coronary microvascular obstruction (CMVO, "no-reflow"). CMVO is defined as the absence of adequate myocardial perfusion, despite the restoration of the IRA lumen. The development of CMVO significantly worsens the prognosis and increases mortality.
CMVO has a complex pathogenesis and is development due to following mechanisms: distal microembolism, ischemia-reperfusion injury, persistent endothelial dysfunction, and individual predisposition. These mechanisms can be implemented simultaneously and have different severity. The most significant predictors of CMVO occurrence are: age, time from pain onset to reperfusion, severity of acute heart failure, ineffective thrombolytic therapy, collateral blood flow according to the Rentrop classification, severity of IRA thrombosis according to Thrombolysis in Myocardial Infarction (TIMI) thrombus grade, initial IRA blood flow according to TIMI flow grade, implantation of 3 or more stents, direct IRA stenting, neutrophil and blood glucose levels.
Difficulties in CMVO predicting are caused by the pathogenetic heterogeneity of this complication. Even the best models are moderately accurate. This can be explained by the fact that the models don't use genetic factors that determine endothelial function, microcirculation, hemostasis, and inflammation. Identification of the genetic determinants of the CMVO development can help create a new diagnostic system for CMVO predicting.
Eligibility Criteria
Inclusion Criteria
- informed consent to participate in the study;
- male or female 18 years of age or older;
- type 1 ST-segment elevation MI (according to the criteria of the fourth universal definition of myocardial infarction and current clinical guidelines);
- blood sampling in the operating room (immediately after PCI) and signing the informed consent;
- for the "CMVO+" group: CMVO because of PCI (CMVO is registered according to the criteria from the European Society of Cardiology clinical guidelines);
- for the "CMVO-" group: absence of CMVO after PCI; patient should compliance by sex and age (±5 years) with pair in the "CMVO+" group.
Exclusion Criteria
- late admission (more than 48 hours from the onset of anginal pain) or early post-infarction angina pectoris;
- not 1 type MI;
- complications during PCI (dissection, perforation or acute intraoperative thrombosis of the IRA);
- death during PCI, not due to the CMVO development;
- concomitant terminal pathology (not associated with MI) with a life expectancy less than 1 month.
Data sourced from ClinicalTrials.gov (NCT05355532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.