Assessment of Plaque Vulnerability Using a Novel Technique: Multi-spectral PhotoAcoustic Imaging.

NCT04763603 | Terminated

• 1 other identifier: D18-P007
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Identification of intraplaque haemorrhage using MRI is technically demanding and sometimes uncomfortable. Photoacoustic imaging is a new non-invasive technique combining multi-wavelength infrared laser light and ultrasound imaging, able to discriminate blood and other components in the tissues. The measurement by the multi-spectral photoacoustic imaging is likely to be more acceptable and therefore could replace MRI.

Conditions

Neurology

Keywords

carotid stenosis; Photoacoustic imaging; Laser diode

Outcome Measures

Primary Outcomes (1)

• Evaluation of the device

  The primary outcome is to evaluate the ability of the experimental device to visualize hemorrhage within the plaque. The primary endpoint will therefore be concordance with histology and plaque analysis (ex-vivo reference method) and MRI (invivo reference method).

  18 month

Secondary Outcomes (1)

• Evaluation of anatomical concordance

  18 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The project involves patients with atherosclerotic plaques (either symptomatic or not).

You may qualify if:

• Presence of at least one carotid plaque with a degree of stenosis 70% (NASCET), indication to surgery (endarterectomy),
• Patients with favourable anatomy criteria :
• x Cranio-caudal length of normal or long neck x Cervical adiposity weak or absent x Carotid bifurcation in usual situation (at the level of the mandibular angle or lower) x Normal genicity of subcutaneous tissues x Calcification of arterial moderate or absent
• Patients affiliated to the social health security system.

You may not qualify if:

• Refusal to participate,
• any concomitant chronic condition hampering the realization of ultrasound scanner or MRI (allergy to gel, intolerance or contraindication to gadolinium).
• Unstable patients with plaque claudication inducing procedure acceleration.
• Patients with unfavourable anatomy criteria :
• x Cranio-caudal length of the neck very short x Significant cervical adiposity x Carotid bifurcation higher than the mandibular angle x High echogenic subcutaneous tissue x Calcification marked arterialH2020-ICT-29-2016 no. 731771 Ethics requirements x Patients with fat necks, Presence of extensive calcifications at the site of the stenosis.
• Patients unable to consent.
• Pregnant woman or breastfeeding woman

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

Sainte-Anne Hospital

Paris, Île-de-France Region, 75014, France

Location

Related Links

• Cvent projet website

Biospecimen

Retention: SAMPLES WITHOUT DNA

atherosclerotic plaque

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: January 29, 2019
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

FR (1)