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CompletedNCT00844987Updated May 27, 2010

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

An observational study in Acute Coronary Syndrome, sponsored by National Institute of Cardiology, Warsaw, Poland. Completed at 1 site in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-27.

Sponsored by National Institute of Cardiology, Warsaw, Poland · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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 (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.

Read the 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.

02

Conditions studied

  • Acute Coronary Syndrome

Keywords

  • PDGF
  • HGF
  • VEGF
  • ACS
  • markers of myocardial injury
  • Vascular Endothelial Growth Factor
  • Hepatocyte Growth Factor
  • Platelet Derived Growth Factor
  • Strategies in ACS
03

In context

Acute Coronary Syndrome

1,492 studies on the registry are indexed under Acute Coronary Syndrome; 270 are open to participants now.

This study's planned enrollment of 120 is below the median of 500 across 579 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

National Institute of Cardiology, Warsaw, Poland is the lead sponsor of 54 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients admitted to Institute of Cardiology due to ACS

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. known past history of a myocardial infarction;
  2. not signed informed consent.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Biospecimen retention
Samples without dna
06

What researchers measure

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

07

Study locations

1 site
  • Institute of Cardiology, Coronary Care Unit
    Warsaw, 04-628, Poland
08

References and documents

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. PubMed 24049022 ↗
  • 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. PubMed 23313225 ↗
  • 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. PubMed 19939200 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2007, a primary completion of Dec 2009 and a completion of Dec 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2009
First posted
Feb 16, 2009
Start
Jan 2007
Primary completionActual
Dec 2009
CompletionActual
Dec 2009
Last update
May 27, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00844987
Lead sponsor
National Institute of Cardiology, Warsaw, Poland
First posted
Feb 16, 2009
Start date
Jan 2007
Primary completion
Dec 2009
Completion
Dec 2009
Last update
May 27, 2010

Study contacts

Anna Konopka, PhD
study director · Institute of Cardiology, CCU

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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