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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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).


Condition
Cardiovascular Risk Factors
Coronary Artery Disease
Cerebrovascular Disease
Peripheral Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

Plasma samples


Estimated Enrollment: 600
Study Start Date: June 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895725

Contacts
Contact: Peter Marschang, MD +43-512-504-81414 peter.marschang@i-med.ac.at

Locations
Austria
Medical University Innsbruck, Department for Internal Medicine III Recruiting
Innsbruck, Austria, 6020
Contact: Peter Marschang, MD       peter.marschang@i-med.ac.at   
Principal Investigator: Peter Marschang, MD         
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Peter Marschang, MD Medical University Innsbruck
  More Information

No publications provided

Responsible Party: Peter Marschang, Prof. MD, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01895725     History of Changes
Other Study ID Numbers: P-selectin 03-13
Study First Received: June 28, 2013
Last Updated: July 5, 2013
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Peripheral Arterial Disease
Cerebrovascular Disorders
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atherosclerosis
Peripheral Vascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 01, 2014