AtherosclerosisAPCNCT00861653
Atherosclerotic Plaque Characterization
An observational study of Atherosclerosis, run by Piedmont Healthcare at 1 site in United States.
Trial summary
The purpose of this study is to utilize high-resolution CMR carotid imaging for the characterization of carotid wall volumes and plaque content in patients with clinical significant carotid atherosclerosis. Patients who are scheduled to undergo an imaging procedure will be recruited from the cath lab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jul 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed with atherosclerosis
Who may be able to join
- Age range >17 years of age
- Surgical carotid artery disease
- Provide written informed consent and Authorization for Use/Disclosure of PHI
Who cannot join
- History of carotid trauma
- History of middle or large vessel vasculitis
- Refusal to provide written informed consent and Authorization for
- Use/Disclosure of PHI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atherosclerotic Plaque Characterization Using Multispectral, Multicontrast High Resolution Cardiovascular Magnetic Resonance Imaging
The purpose of this study is to utilize high-resolution CMR carotid imaging for the characterization of carotid wall volumes and plaque content in patients with clinical significant carotid atherosclerosis. Patients who are scheduled to undergo an imaging procedure will be recruited from the cath lab. Upon enrollment, blood samples conventional and genetic profiling will be collected. For patients undergoing a carotid endarterectomy, tissue from the carotid vessel will be collected during their procedure. Comparison of the MR images with tissue and/or blood samples will be made. Length of time in the study will be approximately 1 day. There will be no study-related patient follow-up.
- Conditions
- Atherosclerosis
- Keywords
- Atherosclerosis, Subjects diagnosed with atherosclerosis
- Medical subject headings
- Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of plaque that is found in the carotid walls of patients who have atherosclerosis
Measured: 2 years post study initiation
Secondary outcomes (1)
To evaluate the effectiveness of MR imaging in identifying these plaque characteristics
Measured: 2 Years Post Study Initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startOct 2006
- Primary completionAug 2011
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piedmont Healthcare
- Sponsor type
- University, hospital or other
- Investigators
- Sarah Rinehart, MD, Principal investigator, Piedmont Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861653
- Sponsor's protocol ID
- P06-31
- Acronym
- APC
- Status last verified
- Apr 2014
- First submitted
- 11 Mar 2009
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atherosclerotic Plaque Characterization Using Multispectral, Multicontrast High Resolution Cardiovascular Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00861653
- Acronym / sponsor ID
- APC / P06-31
- Conditions
- Atherosclerosis
- Keywords
- Atherosclerosis, Subjects diagnosed with atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Piedmont HealthcareUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Mar 2009 (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 purpose of this study is to utilize high-resolution CMR carotid imaging for the characterization of carotid wall volumes and plaque content in patients with clinical significant carotid atherosclerosis. Patients who are scheduled to undergo an imaging procedure will be recruited from the cath lab. Upon enrollment, blood samples conventional and genetic profiling will be collected. For patients undergoing a carotid endarterectomy, tissue from the carotid vessel will be collected during their procedure. Comparison of the MR images with tissue and/or blood samples will be made. Length of time in the study will be approximately 1 day. There will be no study-related patient follow-up.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with atherosclerosis
Key inclusion criteria (3 listed)
- Age range >17 years of age
- Surgical carotid artery disease
- Provide written informed consent and Authorization for Use/Disclosure of PHI
Key exclusion criteria (4 listed)
- History of carotid trauma
- History of middle or large vessel vasculitis
- Refusal to provide written informed consent and Authorization for
- Use/Disclosure of PHI
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
Characterization of plaque that is found in the carotid walls of patients who have atherosclerosis
Time frame: 2 years post study initiation
1 secondary outcome
To evaluate the effectiveness of MR imaging in identifying these plaque characteristics
Time frame: 2 Years Post Study Initiation
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 15 Apr 2014.
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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.
Sarah Rinehart, MD principal investigator
Piedmont Healthcare
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 Piedmont Healthcare at 1 site in United States.
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 3 inclusion and 4 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 15 Apr 2014. 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 United States. 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.
What does the primary outcome measure?
Characterization of plaque that is found in the carotid walls of patients who have atherosclerosis (time frame: 2 years post study initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2014.