Vascular Endothelial Growth Factor (VEGF), Platelet Derived Growth Factor (PDGF), Hepatocyte Growth Factor (HGF) in Patients With Acute Coronary Syndrome (ACS)
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Purpose
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 (PTCA,CABG), 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 i.e. just after admission to hospital and 24h later. Area of a myocardial injury will be estimated by echocardiography examination.
| Condition |
|---|
|
Acute Coronary Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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. |
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Left ventricular function [ Time Frame: hospital stay ] [ Designated as safety issue: Yes ]
- symptoms of heart failure [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- symptoms of angina [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Death [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
serum and plasma
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients admitted to Institute of Cardiology due to ACS
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.
Contacts and Locations| Poland | |
| Institute of Cardiology, Coronary Care Unit | |
| Warsaw, Poland, 04-628 | |
| Study Director: | Anna Konopka, PhD | Institute of Cardiology, CCU |
More Information
No publications provided by Institute of Cardiology, Warsaw, Poland
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anna Konopka MD PhD, Institute of Cardiology, CCU, Warsaw, Poland |
| ClinicalTrials.gov Identifier: | NCT00844987 History of Changes |
| Other Study ID Numbers: | 2.32/II/06, 937 |
| Study First Received: | February 13, 2009 |
| Last Updated: | May 26, 2010 |
| Health Authority: | Poland: Ministry of Science and Higher Education |
Keywords provided by Institute of Cardiology, Warsaw, Poland:
|
PDGF HGF VEGF ACS markers of myocardial injury |
Vascular Endothelial Growth Factor Hepatocyte Growth Factor Platelet Derived Growth Factor Strategies in ACS |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain Pain |
Signs and Symptoms Mitogens Endothelial Growth Factors Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013