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

NCT ID: NCT02650934

Last Updated: 2016-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

312 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure and ST Elevation Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adverse remodelling

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

Percutanous coronary intervention

Intervention Type PROCEDURE

not adverse remodelling

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

Percutanous coronary intervention

Intervention Type PROCEDURE

Interventions

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Percutanous coronary intervention

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Diskapi Training and Research Hospital

OTHER

Sponsor Role collaborator

Ankara City Hospital Bilkent

OTHER

Sponsor Role collaborator

Ankara Training and Research Hospital

OTHER

Sponsor Role collaborator

Dr. Nafiz Korez Sincan State Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Omer Sahin, MD

Role: STUDY_CHAIR

Dr.Nafiz Korez state hospital

Locations

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Dr.Nafiz Korez state hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ferhat Eyyupkoca, MD

Role: CONTACT

+905056864352

Ahmet G Ertem, MD

Role: CONTACT

+905323944334

Facility Contacts

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Ferhat Eyyupkoca, MD

Role: primary

+905056864352

Role: backup

+905325221520

References

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Orn S, Ueland T, Manhenke C, Sandanger O, Godang K, Yndestad A, Mollnes TE, Dickstein K, Aukrust P. Increased interleukin-1beta levels are associated with left ventricular hypertrophy and remodelling following acute ST segment elevation myocardial infarction treated by primary percutaneous coronary intervention. J Intern Med. 2012 Sep;272(3):267-76. doi: 10.1111/j.1365-2796.2012.02517.x. Epub 2012 Feb 26.

Reference Type RESULT
PMID: 22243053 (View on PubMed)

Palazzuoli A, Beltrami M, Gennari L, Dastidar AG, Nuti R, McAlindon E, Angelini GD, Bucciarelli-Ducci C. The impact of infarct size on regional and global left ventricular systolic function: a cardiac magnetic resonance imaging study. Int J Cardiovasc Imaging. 2015 Jun;31(5):1037-44. doi: 10.1007/s10554-015-0657-3. Epub 2015 Apr 12.

Reference Type RESULT
PMID: 25863669 (View on PubMed)

Scott AE, Semple SI, Redpath TW, Hillis GS. Low-dose dobutamine adds incremental value to late gadolinium enhancement cardiac magnetic resonance in the prediction of adverse remodelling following acute myocardial infarction. Eur Heart J Cardiovasc Imaging. 2013 Sep;14(9):906-13. doi: 10.1093/ehjci/jes320. Epub 2013 Jan 12.

Reference Type RESULT
PMID: 23313958 (View on PubMed)

Other Identifiers

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114S309

Identifier Type: -

Identifier Source: org_study_id

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