Ignite Creation Date:
2024-05-05 @ 11:00 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01233336
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2010-11-02
Brief Title:
Hepatocyte Growth Factor HGF Concentration in Myocardial Infarction
Sponsor:
National Institute of Cardiology Warsaw Poland
Organization:
National Institute of Cardiology Warsaw Poland
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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 andor 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 3rehospitalization 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
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 ie 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 andor 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 3rehospitalization 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None