Heart Failure and ST Elevation Myocardial InfarctionHF-EXPRESSNCT02650934
Predictors of Heart Failure After ST-segment Elevation Myocardial Infarction (HF-EXPRESS)
An observational study of Heart Failure and ST Elevation Myocardial Infarction, run by Dr. Nafiz Korez Sincan State Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure and ST Elevation Myocardial Infarction
- What is being tested?
- Percutanous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 312 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2015to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-80 years old patients with myocardial infarction in the first 12 hours
Who may be able to join
- 18-80 years old patients with myocardial infarction in the first 12 hours TIMI 3 flow following PCI
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr.Nafiz Korez state hospital
Ankara, 06810
Ferhat Eyyupkoca, MD, +905056864352, ferhateyupkoca@hotmail.com
+905325221520
About this study
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.
Read the 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.
- Being tested
- Percutanous coronary intervention
- Keywords
- STEMI, Heart Failure, Inflammation, Haptoglobin Polymorphisms, Adverse Remodeling, Genetics, GWAS, MRI
- Medical subject headings
- Heart Failure, ST Elevation Myocardial Infarction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutanous coronary interventionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Adverse remodelling | EF below 40% following MI and remain below 40% after reperfusion Receives: Procedure: Percutanous coronary intervention | |
| not adverse remodelling | EF below 40% following MI and remodelling after reperfusion or EF above 40 % following MI Receives: Procedure: Percutanous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death, nonfatal MI, stroke
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure and ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Nafiz Korez Sincan State Hospital
- Sponsor type
- Other government
- Collaborators
- Ankara Diskapi Training and Research Hospital, Ankara City Hospital Bilkent, Ankara Training and Research Hospital
- Responsible party
- Sponsor
- Investigators
- Omer Sahin, MD, Study chair, Dr.Nafiz Korez state hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650934
- Sponsor's protocol ID
- 114S309
- Acronym
- HF-EXPRESS
- Status last verified
- Jun 2015
- First submitted
- 7 Jan 2016
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22243053Palazzuoli 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.
PubMed 25863669Scott 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.
PubMed 23313958
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Heart Failure After ST-segment Elevation Myocardial Infarction (HF-EXPRESS)
- ClinicalTrials.gov ID
- NCT02650934
- Acronym / sponsor ID
- HF-EXPRESS / 114S309
- Keywords
- STEMI, Heart Failure, Inflammation, Haptoglobin Polymorphisms, Adverse Remodeling, Genetics, GWAS, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Dr. Nafiz Korez Sincan State HospitalOther government
- Collaborators
- Ankara Diskapi Training and Research Hospital, Ankara City Hospital Bilkent, Ankara Training and Research Hospital
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adverse remodelling | – | Procedure: Percutanous coronary interventionEF below 40% following MI and remain below 40% after reperfusion |
| not adverse remodelling | – | Procedure: Percutanous coronary interventionEF below 40% following MI and remodelling after reperfusion or EF above 40 % following MI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-80 years old patients with myocardial infarction in the first 12 hours
Key inclusion criteria (1 listed)
- 18-80 years old patients with myocardial infarction in the first 12 hours TIMI 3 flow following PCI
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutanous coronary intervention | Procedure or surgery | Adverse remodelling, not adverse remodelling |
Primary outcome
Cardiovascular death, nonfatal MI, stroke
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Results publication: PubMed 22243053Orn 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.
- Results publication: PubMed 25863669Palazzuoli 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.
- Results publication: PubMed 23313958Scott 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer Sahin, MD study chair
Dr.Nafiz Korez state hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and ST Elevation Myocardial Infarction, run by Dr. Nafiz Korez Sincan State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferhat Eyyupkoca, MD (+905056864352, ferhateyupkoca@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular death, nonfatal MI, stroke (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02650934, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.