NCT02650934

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
312

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 8, 2016

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

January 7, 2016

Last Update Submit

January 7, 2016

Conditions

Heart Failure and ST Elevation Myocardial Infarction

Keywords

STEMI, Heart Failure, Inflammation, Haptoglobin Polymorphisms, Adverse Remodeling, Genetics, GWAS, MRI

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular death, nonfatal MI, stroke

    2 years

Study Arms (2)

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

Interventions

Percutanous coronary interventionPROCEDURE
Adverse remodellingnot adverse remodelling

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

18-80 years old patients with myocardial infarction in the first 12 hours

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr.Nafiz Korez state hospital

Ankara, 06810, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 22243053RESULT

  • 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.

    PMID: 25863669RESULT

  • 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.

    PMID: 23313958RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood specimen

MeSH Terms

Conditions

Heart FailureST Elevation Myocardial InfarctionInflammation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial InfarctionMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Omer Sahin, MD

    Dr.Nafiz Korez state hospital

    STUDY CHAIR

Central Study Contacts

Ferhat Eyyupkoca, MD

CONTACT

+905056864352ferhateyupkoca@hotmail.com

Ahmet G Ertem, MD

CONTACT

+905323944334agertem@hotmail.com

Study Design

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

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 8, 2016

Study Start

June 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2019

Last Updated

January 8, 2016

Record last verified: 2015-06

Locations

TU(1)