Predictors of Heart Failure After ST-segment Elevation Myocardial Infarction (HF-EXPRESS)

Sponsor
Dr. Nafiz Korez Sincan State Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02650934
Collaborator
Ankara Diskapi Training and Research Hospital (Other), Ankara City Hospital Bilkent (Other), Ankara Training and Research Hospital (Other)
312
1
48
6.5

Study Details

Study Description

Brief Summary

Objective: The purpose of this project is to study the post miyocardial infaction (MI) damage and subsequently developed post-infarct cardiac repair process on the basis of cellular, molecular and imaging techniques. Besides this, whole genomesequencing and analysis (GWAS) will be performed to determine common varying genetic loci in order to anticipate whetherthese findings and its related pathways would be the predictors of adverse remodeling after MI or not.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutanous coronary intervention

Detailed Description

A brief description of the issue and the original value of the subject: Epidemiological studies show a clear increase ininfarct-related complications due to increased survival after MI and aging population. Heart failure is the most prevalent complication after MI, which has reached epidemic proportions in western societies. For the period between 2010 and 2030,according to projections made in developed countries, about 10% increment in all cardiovascular disease is being predictedhowever increment in heart failure (HF) would be such a dramatic figure which is about 25%. HF is an increasing burden tosociety and healthcare systems, since its prevalence and incidence is dramatically increasing. There has not been aprospective study that assesses the exact cellular and geometric course after MI in human. This study will allow us tounderstand the behavior of cells involved in cardiac repair after MI. In addition, it will show us the exact functional andgeometric course after MI. Finally, the current study will also provide novel diagnostic and therapeutic targets via genomic andproteomic studies. All together, we envision to find new efficient ways to identify/treat patients at risk to develop HF after MI.

Study Design

Study Type:
Observational
Anticipated Enrollment :
312 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2018
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Adverse remodelling

EF below 40% following MI and remain below 40% after reperfusion

Procedure: Percutanous coronary intervention

not adverse remodelling

EF below 40% following MI and remodelling after reperfusion or EF above 40 % following MI

Procedure: Percutanous coronary intervention

Outcome Measures

Primary Outcome Measures

  1. Cardiovascular death, nonfatal MI, stroke [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

18-80 years old patients with myocardial infarction in the first 12 hours TIMI 3 flow following PCI

Exclusion Criteria:

Right ventiricular myocardial infarction Cardiogenic shock History of CABG, PCI or valvular disease History of Cardiomyopathy severe LV hypertrophy No reflow after PCI Chronic kidney disease (GFR<60) Systemic inflammatory disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr.Nafiz Korez state hospital Ankara Turkey 06810

Sponsors and Collaborators

  • Dr. Nafiz Korez Sincan State Hospital
  • Ankara Diskapi Training and Research Hospital
  • Ankara City Hospital Bilkent
  • Ankara Training and Research Hospital

Investigators

  • Study Chair: Omer Sahin, MD, Dr.Nafiz Korez state hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Nafiz Korez Sincan State Hospital
ClinicalTrials.gov Identifier:
NCT02650934
Other Study ID Numbers:
  • 114S309
First Posted:
Jan 8, 2016
Last Update Posted:
Jan 8, 2016
Last Verified:
Jun 1, 2015

Study Results

No Results Posted as of Jan 8, 2016