Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin

This study is currently recruiting participants.
Verified July 2013 by Medical University Innsbruck
Sponsor:
Information provided by (Responsible Party):
Peter Marschang, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01895725
First received: June 28, 2013
Last updated: July 5, 2013
Last verified: July 2013

June 28, 2013
July 5, 2013
June 2013
June 2017   (final data collection date for primary outcome measure)
Correlation between P-selectin and the progression of atherosclerosis [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
The primary endpoint of the planned study will be the correlation between P-selectin and the progression of atherosclerosis as measured by plaque volume and IMT in the carotid and femoral arteries
Same as current
Complete list of historical versions of study NCT01895725 on ClinicalTrials.gov Archive Site
Correlation of cardiovascular events with the progression of atherosclerosis [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
As secondary endpoints, cardiovascular events (cardiovascular death, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA), coronary bypass surgery, stroke, transient ischemic attack (TIA), surgery for aortic aneurysm, critical limb ischemia, peripheral percutaneous transluminal angioplasty (PTA), peripheral bypass) will be correlated with the progression of atherosclerosis and the additional predictive value of plaque volume and IMT in carotid and or femoral arteries compared to an established clinical risk score risk score (SCORE card) will be calculated
Same as current
Not Provided
Not Provided
 
Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin
Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin

The proposed project is a prospective observational, single-center cohort study aimed to examine the progression of atherosclerotic alterations of the carotid arteries (IMT, plaque volume) during a follow-up of up to four years and to correlate the observed changes with traditional and novel biomarkers of atherosclerosis. A total of 600 subsequent patients with or established cardiovascular disease or at least one cardiovascular risk will be tested with a high-frequency ultrasound probe equipped with automated IMT measurements and 3D quantitative plaque volumetry. Plasma samples will be collected and tested for traditional and novel cardiovascular risk factors. Both ultrasound examinations and blood sampling will be repeated once per year to assess changes in these parameters over time depending on treatment modalities, which are left to the discretion of the treating physicians. The primary endpoint of the planned study will be the correlation between P-selectin and the progression of atherosclerosis as measured by plaque volume and IMT in the carotid and femoral arteries, respectively. Secondary endpoints will include the correlation of established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors (hsCRP, P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion molecule-1 (ICAM-1), CETP TaqIb polymorphism) with the progression of atherosclerosis, the correlation of cardiovascular events with the progression of atherosclerosis and the additional predictive value of plaque volume and IMT compared to an established risk score (SCORE card).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma samples

Non-Probability Sample

Patients referred to ultrasound examinations of the carotid and/or femoral arteries for standard indications will be screened for potential inclusion into the study

  • Cardiovascular Risk Factors
  • Coronary Artery Disease
  • Cerebrovascular Disease
  • Peripheral Artery Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
June 2017
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients (male and female) aged 30 to 85 years
  • with at least one traditional cardiovascular risk factor (hypertension, smoking, diabetes, dyslipidemia, family history) or established coronary artery disease, cerebrovascular disease, or peripheral artery disease diagnosed by objective testing

Exclusion Criteria:

  • lack of informed consent
  • the impossibility of follow-up testing once per year for the following four years
Both
30 Years to 85 Years
No
Contact: Peter Marschang, MD +43-512-504-81414 peter.marschang@i-med.ac.at
Austria
 
NCT01895725
P-selectin 03-13
No
Peter Marschang, Medical University Innsbruck
Medical University Innsbruck
Not Provided
Principal Investigator: Peter Marschang, MD Medical University Innsbruck
Medical University Innsbruck
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP