NCT04296253

Brief Summary

The purpose of this study is to explore the serum levels of pro- and anti-inflammatory biomarkers and angiogenic growth factors and SNP polymorphisms of the promoter regions of their genes as well as to determine their role in the development of adverse cardiac remodeling in patients with acute ST-segment elevation myocardial infarction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2019

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

1.5 years

First QC Date

March 31, 2019

Last Update Submit

October 5, 2021

Conditions

Myocardial Infarction

Keywords

remodelinginflammationpolymorphismendotoxinheart failure

Outcome Measures

Primary Outcomes (1)

  • Change in the left ventricular end-diastolic volume index (percent)

    Change in the left ventricular end-diastolic volume index (percent) is assessed in patients with myocardial infarction at 1-year follow-up with intermediate assessments at day 7 and month 3 after onset.

    1 year

Secondary Outcomes (9)

  • Incidence of mortality (percent)

    1 year

  • Incidence of stroke (percent)

    1 year

  • Incidence of unstable angina (percent)

    1 year

  • Incidence of chronic heart failure > II NYHA (percent)

    1 year

  • Incidence of recurrent myocardial infarction (percent)

    1 year

  • +4 more secondary outcomes

Other Outcomes (2)

  • CE 1: cardiovascular mortality + myocardial reinfarction + unstable angina (percent)

    1 year

  • CE 2: cardiovascular mortality + myocardial reinfarction + chronic heart failure > II NYHA (percent)

    1 year

Interventions

SNP polymorphisms of the promoter regions pro - and anti-inflammatory cytokines and angiogenic growth factorGENETIC

blood sampling

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute myocardial infarction with ST segment elevation, who underwent coronary angiography within 24 hours of the onset of the disease.

You may qualify if:

  • Age ≥ 18 years at time of randomization
  • Patients with acute coronary syndrome with ST segment elevation
  • Signed informed consent to participate in the study
  • Admission to the intensive care unit within 24 hours from the onset of the disease
  • Coronary angiography within 24 hours of the onset of the disease

You may not qualify if:

  • Long persistent form of atrial fibrillation
  • Valvular heart disease
  • Shock of different genesis
  • Multiple organ failure
  • Chronic heart failure with a severe decrease in the left ventricular ejection fraction
  • Sepsis
  • Severe concomitant pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Research Institute of Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Tomskii Region, 634012, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be obtained from patients with acute ST segment elevation myocardial infarction, who underwent coronary angiography within 24 hours of the onset of the disease.

MeSH Terms

Conditions

Myocardial InfarctionInflammationHeart Failure

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Vyacheslav Ryabov, MD, PhD

    Cardiology Research Institute, Tomsk NRMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director for Research and Clinical Services of Cardiology Research Institute, Head of Department of Emergency Cardiology, Clinical Professor, Principal Invastigator

Study Record Dates

First Submitted

March 31, 2019

First Posted

March 5, 2020

Study Start

March 15, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

October 6, 2021

Record last verified: 2021-10

Locations

RU(1)