Haemodynamic and Geometric Factors in Atherosclerosis

NCT03044704 | Active Not Recruiting

• 1 other identifier: AN2016-0189 366/4.4
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a prospective-observational, explorative single-centre cohort study aimed to examine the influence of hemodynamic and geometric parameters on the progression of atherosclerotic alterations in peripheral vessels (carotids, femoral artery). Atherosclerotic alterations (IMT, plaque volume) will be measured with a ultrasound (IMT measurements and 3D quantitative plaque volumetry) and magnetic resonance imaging (MRI). Geometric parameters (e.g. carotid/femoral bifurcation angle, carotid/femoral bifurcation area) are assessed with magnetic resonance imaging (MRI) and also 3D ultrasonography. A total of 100 patients with an asymmetrical plaque distribution in carotid and femoral arteries will be tested. Only patients who are already enrolled in the "Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin" (NCT01895725) and who are tested prior for an asymmetrical plaque distribution will be included in this study. MRI will be performed once whereas ultrasound imaging will be be repeated once per year (up to five times) to assess changes in these parameters over time. Also plasma samples will be collected once yearly and tested for traditional and novel cardiovascular risk factors. The primary endpoint of the planned study will be the correlation between geometrical and hemodynamic parameters as stated above 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 geometrical and hemodynamic parameters with 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 cardiovascular event rate, plaque localization, plaque morphology and the additional predictive value of geometrical parameters compared to an established risk score (SCORE card).

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Correlation between geometrical and hemodynamic parameters and the progression of atherosclerosis

  Haemodynamic/geometric parameters will be assessed with MRI and 3D-US. This includes carotid/femoral bifurcation angle, common carotid/femoral area, carotid/femoral bifurcation area, internal and external carotid area, femoral superficial artery area and carotid/femoral bifurcation length. Progression of atherosclerosis will be measured via 3D-US by plaque volume and IMT in the carotid and femoral arteries, respectively.

  up to 1 year

Secondary Outcomes (3)

• Correlation of geometrical and hemodynamic parameters with established and novel risk factors.

  up to 1 year

• Correlation of geometrical and hemodynamic parameters with cardiovascular event rate

  1 year

• Correlation of geometrical and hemodynamic parameters with plaque morphology

  up to 1 year

Eligibility Criteria

• Age: 30 Years - 85 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Only patients who are already enrolled in the "Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin" (NCT01895725) and who are tested prior for an asymmetrical plaque distribution will be included in this study.

You may qualify if:

• asymmetrical (side difference) plaque distribution in carotids/femoral arteries which was tested in at least two prior 3D-ultrasound examinations (absolute side difference in carotid arteries ≥ 30 mm3 or in femoral arteries ≥50 mm3 and relative side difference in carotid arteries/femoral arteries ≥50% )

You may not qualify if:

• actual pregnancy, lactation period, chronic renal insufficiency (GFR\<20ml/min)

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (1)

• Schreinlechner M, Noflatscher M, Kremser C, Steiger R, Gromer J, Theurl M, Kirchmair R, Mayr A, Marschang P. A Large Bifurcation Angle Is Strongly Associated With Increased Plaque Volume and Plaque Progression. JACC Cardiovasc Imaging. 2019 Oct;12(10):2087-2088. doi: 10.1016/j.jcmg.2019.05.006. Epub 2019 Jun 12. No abstract available.

  PMID: 31202757 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Peter Marschang, Prof., MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ao. Univ.Prof.Dr.

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 7, 2017
• Study Start: February 6, 2017
• Primary Completion: November 8, 2019
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)