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

November 2, 2010
February 4, 2013
July 2010
December 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01233336 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
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Hepatocyte Growth Factor (HGF) Concentration in Myocardial Infarction
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

plasma for HGF concentration

Probability Sample

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

  • Acute Coronary Syndrome
  • Myocardial Infarction
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01233336
2.52/VII/10
No
Institute of Cardiology, Warsaw, Poland
Institute of Cardiology, Warsaw, Poland
Not Provided
Not Provided
Institute of Cardiology, Warsaw, Poland
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP