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Completed

NCT Number: NCT00844987

Vascular Endothelial Growth Factor (VEGF), Platelet Derived Growth Factor (PDGF), Hepatocyte Growth Factor (HGF) in Patients With Acute Coronary Syndrome (ACS)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Cardiology, Coronary Care Unit

Warsaw, 04-628, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Left ventricular function

    Time frame: hospital stay

  3. symptoms of heart failure

    Time frame: 3 months

  4. symptoms of angina

    Time frame: 3 months

  5. Death

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Warsaw, Poland

Other

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 16, 2009
Registry last updated
May 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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