Predictors of Heart Failure After ST-segment Elevation My... | NCT02650934

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

NCT02650934

Sponsor

Dr. Nafiz Korez Sincan State Hospital

Status

Unknown status

Last Update Posted

Jan 8, 2016Estimated

Enrollment

312Estimated

Phase

Not provided

Conditions

Heart Failure and ST Elevation Myocardial Infarction

Interventions

Percutanous coronary intervention

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jun 2018Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Jan 7, 2016

First Submission Date that Met QC Criteria

Jan 7, 2016

First Posted Date

Jan 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2016

Last Update Posted Date

Jan 8, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Dr. Nafiz Korez Sincan State HospitalOTHER_GOV

Collaborators

Name	Class
Ankara Diskapi Training and Research Hospital	OTHER
Ankara City Hospital Bilkent	OTHER
Ankara Training and Research Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

312Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Percutanous coronary intervention	Procedure		Adverse remodelling not adverse remodelling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiovascular death, nonfatal MI, stroke		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ferhat Eyyupkoca, MD	Contact	+905056864352		ferhateyupkoca@hotmail.com
Ahmet G Ertem, MD	Contact	+905323944334		agertem@hotmail.com

Overall Officials

Name	Affiliation	Role
Omer Sahin, MD	Dr.Nafiz Korez state hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr.Nafiz Korez state hospital	Recruiting	Ankara		06810	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22243053	Result	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.
25863669

ID	Term
D006333	Heart Failure
D000072657	ST Elevation Myocardial Infarction
D007249	Inflammation

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D009203	Myocardial Infarction
D017202	Myocardial Ischemia