Heart DiseaseCarotidNCT01321476
Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis
An observational study of Heart Disease, run by Piedmont Healthcare.
Trial summary
This study will use excess tissue from endoscopic or surgical procedures to examine the elements of plaque that are found in the carotid walls of patients who have a type of heart and blood vessel disease called atherosclerosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Disease
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing a carotid, liver, and/or intestinal biopsy
Who may be able to join
- Age ≥18 years
- Scheduled for a clinically indicated, standard-of-care carotid endarterectomy (CEA) OR scheduled for a clinically indicated, standard-of- care surgical, laparoscopic or endoscopic intestinal biopsy or excision OR scheduled for a clinically indicated, standard-of-care surgical, laparoscopic or endoscopic liver biopsy or partial resection/excision
- Ability and willingness to consent and Authorization for use of PHI
Who cannot join
- Age ≤18 years
- Inability or unwillingness to consent and Authorization for use of PHI
- FOR CAROTID PATIENTS - history of carotid trauma, that is determined by the Principal Investigator to significantly have changed the carotid tissue structure
- FOR CAROTID PATIENTS - history of middle- or large-vessel vasculitis, that is determined by the Principal Investigator to significantly have changed the carotid tissue structure
About this study
This study will use excess tissue from endoscopic or surgical procedures to examine the elements of plaque that are found in the carotid walls of patients who have a type of heart and blood vessel disease called atherosclerosis. Tissue will be collected from patients undergoing carotid procedures as well as patients undergoing liver and/or intestinal biopsies. This lab study will examine the different types of proteins that play a role in developing heart plaque.
- Conditions
- Heart Disease
- Medical subject headings
- Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrated Plaques
Presence of both liver and intestinally derived lipoprotein particles demonstrated in human atherosclerotic plaques.
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
Why it stopped: Study was never initiated and internal decision to discontinue initiation process
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piedmont Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Joseph Miller, MD, Principal investigator, Piedmont Heart Institute/Piedmont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321476
- Sponsor's protocol ID
- Carotid
- Acronym
- Carotid
- Status last verified
- Jul 2011
- First submitted
- 14 Mar 2011
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis
- ClinicalTrials.gov ID
- NCT01321476
- Acronym / sponsor ID
- Carotid / Carotid
- Conditions
- Heart Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was never initiated and internal decision to discontinue initiation process
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Piedmont HealthcareUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- First posted
- 23 Mar 2011 (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.
This study will use excess tissue from endoscopic or surgical procedures to examine the elements of plaque that are found in the carotid walls of patients who have a type of heart and blood vessel disease called atherosclerosis. Tissue will be collected from patients undergoing carotid procedures as well as patients undergoing liver and/or intestinal biopsies. This lab study will examine the different types of proteins that play a role in developing heart plaque.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a carotid, liver, and/or intestinal biopsy
Key inclusion criteria (3 listed)
- Age ≥18 years
- Scheduled for a clinically indicated, standard-of-care carotid endarterectomy (CEA) OR scheduled for a clinically indicated, standard-of- care surgical, laparoscopic or endoscopic intestinal biopsy or excision OR scheduled for a clinically indicated, standard-of-care surgical, laparoscopic or endoscopic liver biopsy or partial resection/excision
- Ability and willingness to consent and Authorization for use of PHI
Key exclusion criteria (4 listed)
- Age ≤18 years
- Inability or unwillingness to consent and Authorization for use of PHI
- FOR CAROTID PATIENTS - history of carotid trauma, that is determined by the Principal Investigator to significantly have changed the carotid tissue structure
- FOR CAROTID PATIENTS - history of middle- or large-vessel vasculitis, that is determined by the Principal Investigator to significantly have changed the carotid tissue structure
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
Demonstrated Plaques
Time frame: up to 30 months
Presence of both liver and intestinally derived lipoprotein particles demonstrated in human atherosclerotic plaques.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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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.
Joseph Miller, MD principal investigator
Piedmont Heart Institute/Piedmont Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease, run by Piedmont Healthcare.
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: withdrawn, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Demonstrated Plaques (time frame: up to 30 months). 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 5 Sep 2013.