Search for Methods to Predict the Development of Heart Failure After Myocardial Infarction

NCT05495516 | Unknown DMC

• 1 other identifier: L-003
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction Despite significant progresses in the diagnosis of myocardial infarction and the development of reperfusion treatment methods, heart failure still often complicates its course. There are three types of postinfarction heart failure: occurring in the acute period, during hospital treatment and after discharge. Factors contributing to heart failure during hospitalization for MI and after discharge include comorbidity of the patient, worsening of pre-existing CHF and comorbidities. In the last decades we can observe higher level of myocardial percutaneous coronary intervention (PCI), improvement of pre-hospital care, which decreased mortality and HF; however, the proportion of HF patients with preserved ejection fraction increased. All these factors determine the urgency of the studied problem. Purpose of the study To identify the most significant factors contributing to the development of acute and subacute heart failure after myocardial infarction Materials and methods Retrospective and prospective non-randomized parallel-group analysis of 186 suffered MI (mean age 63.5 y) during one year was performed in this work, and in the main group of patients (86 patients) at 30 days after MI, chronic heart failure over 2F by NYHA was confirmed, and in comparison group (100 patients) CHF was either absent or did not exceed 2F by NYHA. The diagnosis of MI and CHF was made according to national and European guidelines. Both groups received standard therapy for CHF: ACE inhibitors/angiotensin 2/angiotensin receptor antagonists and neprolysin inhibitor (ARNI), β-blockers, mineralocorticoid receptor antagonists (AMCR), SGLT2-receptor inhibitors; anticoagulants, antiplatelet agents, statins, diuretics if necessary were also used. One year after discharge, clinical outcomes were assessed: cardiovascular mortality, repeated hospitalizations due to decompensation of CHF, death from other causes, stroke, repeated myocardial infarction, unscheduled coronary revascularization; telephone contacts were made every month, repeat visits to the clinic - one year later. The results were based on the information collected in the course of telephone contacts and via e-mail; hospitalizations were also monitored by querying the databases of medical institutions.

Conditions

Myocardial Infarction

Keywords

heart failure, myocardial infarction

Outcome Measures

Primary Outcomes (1)

• cardiovascular death, nonfatal myocardial infarction, stroke of any type, hospitalization due to decompensation of chronic heart failure

  The analysis will be performed using the SPSS REGRESSION module

  1 year

Secondary Outcomes (1)

• total mortality

  1 year

Study Arms (2)

active group

The study group consisted of 86 patients with signs of CHF above class 2 (NYHA) 30 days after myocardial infarction.

Genetic: without Intervention

comparison group

This group consisted of 100 patients without signs of CHF or with CHF class 1 (NYHA) 30 days after myocardial infarction.

Genetic: without Intervention

Interventions

without Intervention GENETIC

without Intervention

active group; comparison group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Open prospective non-randomized cohort study by parallel-group method with additional retrospective analysis; 186 patients (mean age 63.5 years) who underwent myocardial infarction from January 2019 to January 2021 and were treated at the regional vascular center No 1 of Novosibirsk City Clinical Hospital No 1 were included. Novosibirsk. The main group included 86 people with signs of CHF above class 2 (NYHA) and the comparison group consisted of 100 people without signs of CHF or with class 1 (NYHA) CHF. The retrospective part of the study will include the period from 1 to 30 days after myocardial infarction, and the prospective part will include a year from the beginning of the myocardial infarction.

You may qualify if:

• women and men aged 18-75 years;
• hospitalization in the cardiology department for treatment of patients with myocardial infarction at City Clinical Hospital No. 1 with confirmed acute myocardial infarction, typical clinical picture, electrocardiography data, results of cardiospecific enzymes (troponin I, MB fraction of creatine phosphokinase (MB-CPK));
• signing of voluntary informed consent to participate in the research work

You may not qualify if:

• acute inflammatory diseases;
• chronic diseases in the phase of exacerbation and/or incomplete remission;
• diabetes mellitus type 1;
• severe hepatic and renal insufficiency (glomerular filtration rate according to CKD-EPI formula \<15 ml/min/1.73m2);
• cardiomyopathy (obstructive, dilative and restrictive);
• hemodynamically significant valvular heart defects;
• thyrotoxicosis, hypothyroidism;
• malignant neoplasms;
• chronic alcoholism, mental disorders;
• absence of signed voluntary informed consent

Sponsors & Collaborators

• Novosibirsk State Medical University: lead
• Novosibirsk State University: collaborator

Study Sites (1)

Novosibirsk State Medical University

Novosibirsk, Novosibirskaja Oblast' (oblast'), 630099, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

rozen blood clot

MeSH Terms

Conditions

Myocardial Infarction; Heart Failure

Interventions

Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Vladimir N. Maximov, professor

  Novosibirsk State Medical University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 10, 2022
• Study Start: January 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2023
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)