Technical Innovation Protocol for MR & US Plaque Imaging: Reproducibility.

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01196221
First received: September 7, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

The aim of this study is to develop non-invasive MRI, and MRS approaches that will quantify the plaque composition and lipid content of plaques and will have the potential for repeated in vivo measurements. Simultaneously this study aims to develop US plaque imaging as a screening tool to select plaque phenotypes of interest for clinical trials (a large LRNC). For plaque composition imaging by MRI the researchers aim to increase scan resolution and decrease scan time. For quantifying plaque lipid content the researchers aim to develop an MRS protocol. Subsequently, the researchers intend to study the reproducibility of plaque composition and lipid content measurements by MRI, MRS and Ultrasound in subjects that have carotid artery plaques.


Condition
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Technical Innovation Protocol for Carotid Plaque Imaging by 3.0 Tesla MRI, MRS and Ultrasound: Reproducibility.

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Enrollment: 30
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with 30 to 70% carotid artery stenosis

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The population will consist of patients with carotid artery plaques that cause 30% to 70% lumen stenosis. The degree of stenosis will be assessed by the peak systolic velocity end end diastolic velocity near the stenosis measured by ultrasound duplex.

The researchers choose to investigate patients with 30% to 70% carotid artery stenosis for the following reasons: 1. Treatment of patients with carotid artery plaques is based on the amount of lumen stenosis. A stenosis of more than 70% is generally treated surgically by endarterectomy. Doing repeated measurements is only possible in patients not treated surgically. 2. Patients with 30% to 70% carotid artery stenosis are, despite their drug treatment, still at high risk for cardiovascular events.

Criteria

Inclusion Criteria:

  • Patients, with 30 to 70% carotid artery stenosis on ultrasound duplex, who will not go for endarterectomy.

Exclusion Criteria:

  • Metal in the body, as a result of e.g. pacemaker or artificial cardiac valves; claustrophobia; surgery performed in the area of measurement (Carotid artery region); Cardiac arrhythmias.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196221

Locations
Netherlands
Academic Medical Center
Amsterdam, NH, Netherlands, 1105AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Erik Stroes, MD PhD AIDS Malignancy Clinical Trials Consortium
  More Information

Publications:
Responsible Party: E.S. stroes, AMC
ClinicalTrials.gov Identifier: NCT01196221     History of Changes
Other Study ID Numbers: TIP-R
Study First Received: September 7, 2010
Last Updated: September 7, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014