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Haemodynamic and Geometric Factors in Atherosclerosis (ANGLE)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044704
Recruitment Status : Unknown
Verified September 2017 by Peter Marschang, Medical University Innsbruck.
Recruitment status was:  Recruiting
First Posted : February 7, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Marschang, Medical University Innsbruck

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).


Condition or disease
Atherosclerosis

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Haemodynamic and Geometric Factors on the Onset and Progression of Atherosclerosis
Actual Study Start Date : February 6, 2017
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044704


Contacts
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Contact: Michael Schreinlechner, MD 004351250481308 Michael.Schreinlechner@i-med.ac.at
Contact: Peter Marschang, Prof.,MD 004351250481414 Peter.Marschang@i-med.ac.at

Locations
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Austria
Medical University of Innsbruck Recruiting
Innsbruck, Tyrol, Austria, 6020
Contact: Michael Schreinlechner, MD    004351250481308    Michael.Schreinlechner@i-med.ac.at   
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Peter Marschang, Prof., MD Medical University Innsbruck

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Responsible Party: Peter Marschang, Ao. Univ.Prof.Dr., Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT03044704    
Other Study ID Numbers: AN2016-0189 366/4.4
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases