NCT01233336

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

2.4 years

First QC Date

November 2, 2010

Last Update Submit

February 4, 2013

Conditions

Keywords

ACS,HGF,myocardial infarctionmarkers of myocardial injuryacute coronary syndrome (ACS)prognostic factors in patients with ACS

Outcome Measures

Primary Outcomes (1)

  • composite end point

    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

    6-month follow -up

Secondary Outcomes (3)

  • death

    6- month follow-up

  • symptoms of heart failure

    6-month follow-up

  • rehospitalisation due to cardiovascular reasons

    6- month follow-up

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • age \< 18 years,
  • not signed informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiology , CCU, ul. Alpejska 42

Warsaw, 04-628, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma for HGF concentration

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

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

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 3, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations