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

This study has been completed.
Sponsor:
Information provided by:
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT00844987
First received: February 13, 2009
Last updated: May 26, 2010
Last verified: May 2010
  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.

Resource links provided by NLM:


Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted to Institute of Cardiology due to ACS

Criteria

Inclusion Criteria:

  1. typical chest pain;
  2. ST segment elevation or depression in ECG;
  3. indication for coronary angiography; if necessary with PCI and 4) signed inform consent.

Exclusion Criteria:

  1. known past history of a myocardial infarction;
  2. not signed informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844987

Locations
Poland
Institute of Cardiology, Coronary Care Unit
Warsaw, Poland, 04-628
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
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 April 17, 2014