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Haemodynamic and Geometric Factors in Atherosclerosis (ANGLE)

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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

Tracking Information
First Submitted Date January 31, 2017
First Posted Date February 7, 2017
Last Update Posted Date September 28, 2017
Actual Study Start Date February 6, 2017
Estimated Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 3, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 3, 2017)
  • 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).
  • 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)
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Haemodynamic and Geometric Factors in Atherosclerosis
Official Title Influence of Haemodynamic and Geometric Factors on the Onset and Progression of Atherosclerosis
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).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Atherosclerosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Schreinlechner M, Noflatscher M, Kremser C, Steiger R, Grömer 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 3, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2018
Estimated Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages 30 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT03044704
Other Study ID Numbers AN2016-0189 366/4.4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Peter Marschang, Medical University Innsbruck
Study Sponsor Medical University Innsbruck
Collaborators Not Provided
Investigators
Principal Investigator: Peter Marschang, Prof., MD Medical University Innsbruck
PRS Account Medical University Innsbruck
Verification Date September 2017