Cardiac Structure, Function, and Clinical Manifestations in MINOCA

NCT03572023 | Completed

• 1 other identifier: MINOCA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to improve the differential diagnosis and clinical outcomes of acute coronary syndrome with non-obstructive coronary arteries, to investigate the relationship between the structural and functional state of the heart and the clinical course of the disease.

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Keywords

Acute coronary syndrome; Non-obstructive coronary artery atherosclerosis; MINOCA; Myocardial infarction; Proinflammatory interleukins; Thrombophilia; Genetic testing; SPECT; MSCT; MRI

Outcome Measures

Primary Outcomes (1)

• Frequency of unstable plaque occurrence measure

  Frequency of occurrence (%) of unstable plaques (including plaque rupture, plaque erosion, and intracoronary thrombus) according to multispiral computed tomography (MSCT) in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA) 6 days after acute coronary syndrome (ACS)

  6 days

Secondary Outcomes (4)

• Myocardial perfusion transient defect measure

  1 week

• IL-6 measure

  1 week

• Pro-thrombophilic allelic variant measure

  3 days

• Frequency of atherosclerosis occurrence measure

  6 days

Study Arms (2)

MINOCA

ACTIVE COMPARATOR

This group will include patients with myocardial infarction with non-obstructive coronary arteries (MINOCA). Integrative characterization of MINOCA patients: The following interventions will be administered: MSCT, CMR, SPECT, Blood tests, Genetic tests.

Other: Integrative characterization of MINOCA patients

MI with coronary obstruction

ACTIVE COMPARATOR

This group will include patients with myocardial infarction and obstructive coronary arteries. Characterization of MI patients with coronary obstruction: The following interventions will be administered: MSCT, CMR, SPECT, Blood tests, Genetic tests.

Other: Characterization of MI patients with coronary obstruction

Interventions

Integrative characterization of MINOCA patients OTHER

Characterization of MINOCA patients will be based on integrative evaluation of imaging data, blood levels of proinflammatory and anti-inflammatory cytokines, and genetic testing for thrombophilia risk. MSCT: Imaging for the presence and vulnerability of coronary plaque as well as plaque disruption. CMR: Imaging for identification of myocardial injury (late gadolinium enhancement and myocardial edema) as well as other concomitant findings. SPECT: Single-Photon Emission Computed Tomography enable assessment of myocardial perfusion and viability. Blood tests. Genetic tests.

MINOCA

Characterization of MI patients with coronary obstruction OTHER

Characterization of patients with myocardial infarction and obstructive atherosclerosis will be based on integrative evaluation of imaging data, blood levels of proinflammatory and anti-inflammatory cytokines, and genetic testing for thrombophilia risk. MSCT: Imaging for the presence and vulnerability of coronary plaque as well as plaque disruption. CMR: Imaging for identification of myocardial injury (late gadolinium enhancement and myocardial edema) as well as other concomitant findings. SPECT: Single-Photon Emission Computed Tomography enable assessment of myocardial perfusion and viability. Blood tests. Genetic tests.

MI with coronary obstruction

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years at time of enrolment (18 years and older)
• Patients with ACS with and without ST-segment elevation who underwent coronary angiography within 24 h after onset of the disease
• High cardiovascular risk by GRACE Risk Score
• The absence of obstructive coronary atherosclerosis (normal coronary artery / plaques \<50%) is based on the results of coronary angiography
• Sinus rhythm on electrocardiogram
• Written informed consent to participate in research

You may not qualify if:

• Patients previously undergone endovascular / surgical revascularization of coronary artery
• Severe comorbidity
• Severe renal failure (eGFR \< 30)
• Patients with cardiac pacing and claustrophobia
• Contacts / Locations

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Vyacheslav Ryabov

Tomsk, Tomsk, Tomskii Region, 634012, Russia

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; MINOCA; Thrombophilia

Condition Hierarchy (Ancestors)

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

Study Officials

• Vyacheslav Ryabov, MD, PhD

  Tomsk NRMC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2018
• First Posted: June 28, 2018
• Study Start: May 28, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: April 1, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)