Hepatocyte Growth Factor (HGF) Concentration in Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01233336
First received: November 2, 2010
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

This is the continuation of previous study (registration number: NCT00844987) which revealed that hepatocyte growth factor (HGF) is a very early, good marker of myocardial injury and prognostic factor for post myocardial infarction (MI) cardiovascular events presence in long-term follow-up. Due to potentially very important implication of the results of previous study it was decided to continue research of HGF in patients with MI. Now, is scheduled to examine 100 consecutive patients with STEMI. HGF assessments will be performed just after admission to hospital, 1h and 24h later and before discharge. Two follow-up visits were planned i.e. at 3 and 6 months after MI. During hospitalization and at 6 month visit the echocardiography examination will be performed. The composite primary endpoint consists of cardiovascular events observed during hospital course and in long term-follow-up.


Condition
Acute Coronary Syndrome
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hepatocyte Growth Factor as an Early Marker of Myocardial Injury and Prognostic Factor of Cardiovascular Events in Log-term Follow up in Patients With Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • composite end point [ Time Frame: 6-month follow -up ] [ Designated as safety issue: Yes ]
    death, reinfarction, coronary interventions (PCI and/or CABG) due to new ACS or exacerbation of angina, symptoms of heart failure, rehospitalisation due to cardiovascular events and stroke in context of HGF concentration in acute stage of ACS


Secondary Outcome Measures:
  • death [ Time Frame: 6- month follow-up ] [ Designated as safety issue: Yes ]
    endpoint in context of HGF concentration in early stage of ACS

  • symptoms of heart failure [ Time Frame: 6-month follow-up ] [ Designated as safety issue: Yes ]
    endpoint in context of HGF concentrationin early stage of ACS

  • rehospitalisation due to cardiovascular reasons [ Time Frame: 6- month follow-up ] [ Designated as safety issue: Yes ]
    endpoint in context of HGF concentration in early stage of ACS


Biospecimen Retention:   Samples Without DNA

plasma for HGF concentration


Enrollment: 45
Study Start Date: July 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Hepatocyte growth factor (HGF) was examined in study number NCT00844987 as a potentially useful marker of acute myocardial injury. Results of the study confirmed efficacy of HGF as very early marker of myocardial necrosis and as a prognostic factor for cardiovascular events in long term follow up. Recent study is a continuation of previous study.

The aim is to confirm that maximal values of the HGF in first examination performed in ACS (acute coronary syndrome) patients and to show predictive value of HGF for early and late outcome in patients with ACS.

Materials and method: 100 patients with acute coronary syndrome will be included into the study. HGF will be examined four times i.e. just after admission, 1h and 24h latter and before discharge. In case of 10 patients will be performed 10 assessments during first day of ACS.

The follow up visits will take place 3 and 6 months after ACS. During hospitalization and 6 months later echocardiography examination will be performed and the extension of heart dysfunction will be assessed. Control group will consist of 10-15 health volunteers.

The primary endpoint is a composite endpoint which will include following cardiovascular events observed during hospitalization and during 6-month follow up: death, reinfarction, coronary interventions (PCI and/or CABG) due to new ACS or exacerbation of angina, symptoms of heart failure, rehospitalization due to cardiovascular events and stroke in context of HGF concentration in acute stage of ACS.

As a secondary endpoints will be considered: 1) death, 2) symptoms of heart failure 3)rehospitalization due to cardiac events observed during hospitalization or in 6-month follow-up. All this endpoints will consider in context of HGF values and values of routinely measured markers of myocardial injury.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with acute coronary syndrome admitted to CCU due to symptoms of ACS.

Criteria

Inclusion Criteria:

  • age >18 years,
  • chest pain,
  • symptoms of ischemia at ECG,
  • signed informed consent form

Exclusion Criteria:

  • age < 18 years,
  • not signed informed consent form.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01233336

Locations
Poland
Institute of Cardiology , CCU, ul. Alpejska 42
Warsaw, Poland, 04-628
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
  More Information

No publications provided

Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT01233336     History of Changes
Other Study ID Numbers: 2.52/VII/10
Study First Received: November 2, 2010
Last Updated: February 4, 2013
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Institute of Cardiology, Warsaw, Poland:
ACS,
HGF,
myocardial infarction
markers of myocardial injury
acute coronary syndrome (ACS)
prognostic factors in patients with ACS

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Syndrome
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Disease
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014