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

This study is currently recruiting participants.
Verified September 2017 by Peter Marschang, Medical University Innsbruck
Sponsor:
ClinicalTrials.gov Identifier:
NCT01895725
First Posted: July 10, 2013
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter Marschang, Medical University Innsbruck
June 28, 2013
July 10, 2013
September 28, 2017
June 2013
June 2019   (Final data collection date for primary outcome measure)
Correlation between P-selectin and the progression of atherosclerosis [ Time Frame: up to 4 years ]
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 ]
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
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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).
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
June 2019
June 2019   (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
Sexes Eligible for Study: All
30 Years to 85 Years   (Adult, Senior)
No
Contact: Peter Marschang, MD +43-512-504-81414 peter.marschang@i-med.ac.at
Austria
 
 
NCT01895725
P-selectin 03-13
No
Not Provided
Not Provided
Peter Marschang, Medical University Innsbruck
Medical University Innsbruck
Not Provided
Principal Investigator: Peter Marschang, MD Medical University Innsbruck
Medical University Innsbruck
September 2017