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NCT Number: NCT03044704

Haemodynamic and Geometric Factors in Atherosclerosis

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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% )

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Correlation between geometrical and hemodynamic parameters and the progression of atherosclerosis

    Time frame: up to 1 year

    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.

Secondary outcomes

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

    Time frame: up to 1 year

    Secondary endpoint 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 risk constellations compared to an established risk score (SCORE card).

  2. Correlation of geometrical and hemodynamic parameters with cardiovascular event rate

    Time frame: 1 year

    Secondary endpoint will include the correlation of geometrical and hemodynamic parameters with the cardiovascular event rate (MACE-rate, coronary/ femoral surgery/intervention)

  3. Correlation of geometrical and hemodynamic parameters with plaque morphology

    Time frame: up to 1 year

    Secondary endpoint will include the correlation of geometrical and hemodynamic parameters with the plaque morphology (gray-scale median, Gray-Weale scores, plaque surface state)

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

Influence of Haemodynamic and Geometric Factors on the Onset and Progression of Atherosclerosis

Acronym: ANGLE

Important dates

Study start
2017
Primary completion
2019
Study completion
2028
First posted
Feb 7, 2017
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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