- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00844987
Vascular Endothelial Growth Factor (VEGF), Platelet Derived Growth Factor (PDGF), Hepatocyte Growth Factor (HGF) in Patients With Acute Coronary Syndrome (ACS)
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.
Study Overview
Status
Conditions
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 i.e. 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 and/or multivessel disease,
subgroup of patients with "moderate myocardial injury" which will consist of patients with inferior and/or 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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Warsaw, Poland, 04-628
- Institute of Cardiology, Coronary Care Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- typical chest pain;
- ST segment elevation or depression in ECG;
- indication for coronary angiography; if necessary with PCI and 4) signed inform consent.
Exclusion Criteria:
- known past history of a myocardial infarction;
- not signed informed consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite end point of the study which consists of: death, myocardial infarction, exacerbation of angina, heart failure, cardiovascular reintervention, rehospitalization due to cardiovascular reasons, stroke
Time Frame: 3 months
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Death
Time Frame: 3 months
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3 months
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Dynamics of serum and plasma concentration of VEGF, HGF and PDGF and comparison with changes of examined markers of myocardial injury and dysfunction
Time Frame: hospital stay
|
hospital stay
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Left ventricular function
Time Frame: hospital stay
|
hospital stay
|
symptoms of heart failure
Time Frame: 3 months
|
3 months
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symptoms of angina
Time Frame: 3 months
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3 months
|
Collaborators and Investigators
Investigators
- Study Director: Anna Konopka, PhD, Institute of Cardiology, CCU
Publications and helpful links
General Publications
- Konopka A, Janas J, Piotrowski W, Stepinska J. Hepatocyte growth factor - the earliest marker of myocardial injury in ST-segment elevation myocardial infarction. Kardiol Pol. 2013;71(8):827-31. doi: 10.5603/KP.2013.0194.
- Konopka A, Janas J, Piotrowski W, Stepinska J. Concentration of vascular endothelial growth factor in patients with acute coronary syndrome. Cytokine. 2013 Feb;61(2):664-9. doi: 10.1016/j.cyto.2012.12.001. Epub 2013 Jan 10.
- Konopka A, Janas J, Piotrowski W, Stepinska J. Hepatocyte growth factor--a new marker for prognosis in acute coronary syndrome. Growth Factors. 2010 Apr;28(2):75-81. doi: 10.3109/08977190903403984.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2.32/II/06
- 937
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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