Ignite Creation Date:
2024-05-05 @ 9:15 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00844987
Status:
COMPLETED
Last Update Posted:
2010-05-27
First Post:
2009-02-13
Brief Title:
Vascular Endothelial Growth Factor VEGF Platelet Derived Growth Factor PDGF Hepatocyte Growth Factor HGF in Patients With Acute Coronary Syndrome ACS
Sponsor:
National Institute of Cardiology Warsaw Poland
Organization:
National Institute of Cardiology Warsaw Poland
Study Overview
Official Title:
The Importance of Vascular Endothelial Growth Factor VEGF Hepatocyte Growth Factor HGF and Platelet Derived Growth Factor PDGF as a New Indicators of Myocardial Ischemic Injury in Comparison With Commonly Used Biomarkers
Status:
COMPLETED
Status Verified Date:
2010-05
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:
The main aim of the study is a comparison of serum and plasma concentration of VEGF Vascular Endothelial Growth Factor HGF Hepatocyte Growth Factor and PDGF Platelet Derived Growth Factor with markers of myocardial injury as troponin I hsCRP CK-MB and NT-proBNP assessed in patients with first episode of acute coronary syndrome ACS in their lives and the estimation of assumed value of VEGF HGF and PDGF in prognosis of cardiovascular complications at 3 months follow up especially with respect to myocardial infarction MI exacerbation of angina reintervention PTCACABG symptoms of heart failure stroke rehospitalization due to cardiovascular reasons and death The dynamics of changes in serum and plasma concentration of growth factors in comparison with values of myocardial injury markers will be checked For the realization of the purpose of the study biochemical measurements will be performed twice ie just after admission to hospital and 24h later Area of a myocardial injury will be estimated by echocardiography examination
Detailed Description:
In the recent years several biomarkers have been investigated to be used for diagnostic and risk stratification in patients with symptoms of acute coronary syndrome Troponins are preferred markers for myocardial injury due to its high specificity and sensitivity what makes them superior than traditional cardiac enzymes as CK or CK-MB Elevated level of NT-proBNP is a marker of heart failure strongly associated with increased mortality rate This study is invented for searching new sensitive indicators of myocardial injury and predictors of bad outcome in patients with symptoms of ACS especially useful in difficult diagnostic and therapeutic situations
The study is performed in patients with first episode of ACS in their life who are eligible for coronary angiography and eventually for PCI All subjects who agree to participate in the study are informed of its nature and purpose Patients only due to the symptoms and according to ESC guidelines are referred for coronary angiography primary PCI surgery revascularisation and pharmacological treatment Inclusion into the study does not influence on the type of the treatment The measurements of VEGF HGF PDGF troponin I hsCRP CK-MB and NT-proBNP are assessed twice ie as soon as possible after admission to hospital and 24h after the first measurements For estimation of changes in concentration of growth factors in time in some patients the multiple assessments will be performed 9 measurements during first 24h and 1 before discharge from hospital In healthy volunteers 10 to 20 subjects one control measurement of HGF will be performed Three days after ACS symptoms appeared left ventricular function is determined by echocardiography Scheduled control visits are performed after 3 months follow up The demographic and clinical data duration of chest pain results of 12 leads ECG angiographic findings haemodynamic description of cardiac function parameters from echocardiography and ventriculography type of invasive revascularisation and results of performed measurements and examinations will undergo single and multivariable statistical analysis Additionally according to a few clinical and angiographic findings for statistic analysis will be specified either
subgroup of patients with major myocardial injury which will comprise patients with anterior or antero-lateral myocardial infarction MI with occlusion or significant left anterior descending LAD branch stenosis andor multivessel disease
subgroup of patients with moderate myocardial injury which will consist of patients with inferior andor posterior MI and with singlevessel disease but not LAD
subgroup of patients with minor myocardial injury which will include patients with NSTE-ACS Non-ST-Segment Elevation ACS and without a significant increase of myocardial injury markers
The study is performed in patients with first episode of ACS in their life who are eligible for coronary angiography and eventually for PCI All subjects who agree to participate in the study are informed of its nature and purpose Patients only due to the symptoms and according to ESC guidelines are referred for coronary angiography primary PCI surgery revascularisation and pharmacological treatment Inclusion into the study does not influence on the type of the treatment The measurements of VEGF HGF PDGF troponin I hsCRP CK-MB and NT-proBNP are assessed twice ie as soon as possible after admission to hospital and 24h after the first measurements For estimation of changes in concentration of growth factors in time in some patients the multiple assessments will be performed 9 measurements during first 24h and 1 before discharge from hospital In healthy volunteers 10 to 20 subjects one control measurement of HGF will be performed Three days after ACS symptoms appeared left ventricular function is determined by echocardiography Scheduled control visits are performed after 3 months follow up The demographic and clinical data duration of chest pain results of 12 leads ECG angiographic findings haemodynamic description of cardiac function parameters from echocardiography and ventriculography type of invasive revascularisation and results of performed measurements and examinations will undergo single and multivariable statistical analysis Additionally according to a few clinical and angiographic findings for statistic analysis will be specified either
subgroup of patients with major myocardial injury which will comprise patients with anterior or antero-lateral myocardial infarction MI with occlusion or significant left anterior descending LAD branch stenosis andor multivessel disease
subgroup of patients with moderate myocardial injury which will consist of patients with inferior andor posterior MI and with singlevessel disease but not LAD
subgroup of patients with minor myocardial injury which will include patients with NSTE-ACS Non-ST-Segment Elevation ACS and without a significant increase of myocardial injury markers
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 937 | None | None | None |