Haemodynamic & Geometric Factors in Atherosclerosis

Status Active, not recruiting

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Atherosclerosis

Clinical Trial Details

NCT number	NCT03044704
Study type	Observational
Source	Medical University Innsbruck
Contact
Status	Active, not recruiting
Phase
Start date	February 6, 2017
Completion date	January 2028

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05052918` - The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes	N/A
Recruiting	`NCT04511234` - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease	N/A
Completed	`NCT05906797` - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.	N/A
Completed	`NCT03273972` - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers	N/A
Suspended	`NCT02932176` - Machine Learning for Handheld Vascular Studies
Recruiting	`NCT05158257` - Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity	N/A
Completed	`NCT01212900` - Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression	Phase 4
Completed	`NCT03697382` - Effect of Daily Steps on Fat Metabolism	N/A
Recruiting	`NCT06230406` - T-Mem GEne in Atherosclerosis
Completed	`NCT03654313` - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus	Phase 1
Completed	`NCT00382564` - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease	N/A
Recruiting	`NCT02894931` - Effects of Dietary Interventions on Serum and Macrophage Atherogenicity	N/A
Completed	`NCT02998918` - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL	N/A
Not yet recruiting	`NCT02578355` - National Plaque Registry and Database	N/A
Recruiting	`NCT02265250` - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Completed	`NCT02224339` - New Technologies to Determine Carotid Plaque Vulnerability
Completed	`NCT03393377` - Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination	N/A
Completed	`NCT02268513` - Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
Completed	`NCT02377310` - Pd/Pa vs iFR™ in an Unselected Population Referred for Invasive Angiography	N/A
Not yet recruiting	`NCT01923012` - Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Haemodynamic and Geometric Factors in Atherosclerosis — ANGLE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms