Genetic Determinants of the Coronary Microvascular Obstruction in PCI

NCT05355532 | Completed Results DMC

• 1 other identifier: CMVO-SNP-2022
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Myocardial Infarction; No-Reflow Phenomenon

Keywords

coronary microvascular obstruction; no-reflow phenomenon; myocardial infarction; percutaneous coronary intervention; single nucleotide polymorphism; genetics

Outcome Measures

Primary Outcomes (1)

• Hospital Mortality Rate

  Death during index hospitalization.

  up to 7-15 days after PCI

Secondary Outcomes (4)

• Left Ventricle Ejection Fraction

  7-10 day after PCI

• Six-minute Walk Test

  7-10 day after PCI

• N-terminal Pro-brain Natriuretic Peptide

  7-10 day after PCI

• Ventricular Fibrillation

  up to 7-15 days after PCI

Study Arms (2)

"CMVO+" (patients has presented CMVO in PCI)

Patients with 1 type MI that has presented CMVO in emergency PCI.

Genetic: different variants of SNPs that may be associated with the coronary microvascular obstruction development

"CMVO-" (patients hasn't presented CMVO in PCI)

Patients with 1 type MI that hasn't presented CMVO in emergency PCI.

Genetic: different variants of SNPs that may be associated with the coronary microvascular obstruction development

Interventions

different variants of SNPs that may be associated with the coronary microvascular obstruction development GENETIC

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 has presented CMVO in PCI); "CMVO-" (patients hasn't presented CMVO in PCI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with 1 type MI after emergency PCI

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Privolzhsky Research Medical University: lead

Study Sites (2)

City Clinical Hospital No. 13 of the Avtozavodsky District of Nizhny Novgorod

Nizhny Novgorod, Nizhny Novgorod Oblast, 603018, Russia

Location

Central Research Laboratory of the Privolzhsky Research Medical University

Nizhny Novgorod, Nizhny Novgorod Oblast, 603104, Russia

Location

Related Publications (4)

• Frolov AA, Pochinka IG, Shakhov BE, Mukhin AS, Frolov IA, Barinova MK, Sharabrin EG. Using an Artificial Neural Network to Predict Coronary Microvascular Obstruction (No-Reflow Phenomenon) during Percutaneous Coronary Interventions in Patients with Myocardial Infarction. Sovrem Tekhnologii Med. 2021;13(6):6-13. doi: 10.17691/stm2021.13.6.01. Epub 2021 Dec 28.

  PMID: 35265354 BACKGROUND

• Pochinka IG, Frolov AA, Kuzmichev KV, Shchelchkova NA, Pershin VI, Maximova NS, Budkina ML, Predeina IV, Frolov IA, Kashtanov MG. Genetic Scale for Predicting the No-Reflow Phenomenon in Myocardial Infarction. Sovrem Tekhnologii Med. 2025;17(5):74-84. doi: 10.17691/stm2025.17.5.05. Epub 2025 Oct 31.

  PMID: 41426969 RESULT

• Frolov A.A., Pochinka I.G., Kuzmichev K.V., Shchelchkova N.A., Pershin V.I., Maksimova N.S., Budkina M.L., Predeina I.V., Mukhin A.S. Genetic markers of endothelial dysfunction as predictors of coronary microvascular obstruction in endovascular treatment of myocardial infarction. Cardiology: News, Opinions, Training. 2025; 13 (1): 22-30. DOI: 10.33029/2309-1908-2025-13-1-22-30

  RESULT

• Pochinka IG, Shchelchkova NA, Frolov AA, Pershin VI, Maksimova NS, Kuzmichev RV, Budkina ML, Predeina IV, inventors. Privolzhsky Research Medical University, assignee. Method of diagnosing genetic predisposition to development of phenomenon of coronary microvascular obstruction during percutaneous coronary interventions in patients with myocardial infarction with ST segment elevation. Russian Federation patent RU 2,811,933. 2023 Oct 26.

  RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Venous peripheral blood

MeSH Terms

Conditions

Myocardial Infarction; No-Reflow Phenomenon

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Ilya Pochinka, MD
• Organization: Privolzhsky Research Medical University

pochinka4@yandex.ru

+79030561932

Study Officials

• Ilya Pochinka, MD

  Privolzhsky Research Medical University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: May 2, 2022
• Study Start: April 11, 2022
• Primary Completion: March 5, 2023
• Study Completion: March 25, 2023
• Last Updated: February 17, 2026
• Results First Posted: September 25, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)