AtherosclerosisNCT01196221
Technical Innovation Protocol for MR & US Plaque Imaging: Reproducibility.
An observational study of Atherosclerosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atherosclerosis
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients, with 30 to 70% carotid artery stenosis on ultrasound duplex, who will not go for endarterectomy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1105AZ
About this study
Official title: Technical Innovation Protocol for Carotid Plaque Imaging by 3.0 Tesla MRI, MRS and Ultrasound: Reproducibility.
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.
- Conditions
- Atherosclerosis
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with 30 to 70% carotid artery stenosis | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startNov 2009
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Erik Stroes, MD PhD, Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196221
- Sponsor's protocol ID
- TIP-R
- Status last verified
- Sep 2010
- First submitted
- 7 Sep 2010
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Duivenvoorden R, Vanbavel E, de Groot E, Stroes ES, Disselhorst JA, Hutten BA, Lameris JS, Kastelein JJ, Nederveen AJ. Endothelial shear stress: a critical determinant of arterial remodeling and arterial stiffness in humans--a carotid 3.0-T MRI study. Circ Cardiovasc Imaging. 2010 Sep;3(5):578-85. doi: 10.1161/CIRCIMAGING.109.916304. Epub 2010 Jun 24.
PubMed 20576811
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Innovation Protocol for Carotid Plaque Imaging by 3.0 Tesla MRI, MRS and Ultrasound: Reproducibility.
- ClinicalTrials.gov ID
- NCT01196221
- Acronym / sponsor ID
- TIP-R
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 8 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with 30 to 70% carotid artery stenosis | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients, with 30 to 70% carotid artery stenosis on ultrasound duplex, who will not go for endarterectomy.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
- Background: PubMed 20576811Duivenvoorden R, Vanbavel E, de Groot E, Stroes ES, Disselhorst JA, Hutten BA, Lameris JS, Kastelein JJ, Nederveen AJ. Endothelial shear stress: a critical determinant of arterial remodeling and arterial stiffness in humans--a carotid 3.0-T MRI study. Circ Cardiovasc Imaging. 2010 Sep;3(5):578-85. doi: 10.1161/CIRCIMAGING.109.916304. Epub 2010 Jun 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Stroes, MD PhD principal investigator
AIDS Malignancy Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01196221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2010.