Coronary AtherosclerosisPhase 1NCT01642173
Assessment of Coronary Plaque Composition Using Optical Coherence Tomography
A Phase 1 study testing Optical Coherence Tomography (C7 XR Dragonfly ) in people with Coronary Atherosclerosis and Endothelial Dysfunction, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigator's hypothesis is that local activation of the endogenous Lp-PLA2 plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Atherosclerosis, Endothelial Dysfunction, Coronary Small Vessel Disease
- What is being tested?
- Optical Coherence Tomography (C7 XR Dragonfly )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2015
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years and < 85 years
- referred to our cardiac catheterization laboratory for coronary vasomotion testing
- are found to have coronary endothelial dysfunction.
Who cannot join
- these include heart failure
- ejection fraction < 40%
- unstable angina
- myocardial infarction or angioplasty within 6 months prior to entry into the study
- use of investigational agents within 1 month of entry into the study,
- patients who require treatment with positive inotropic agents other than digoxin during the study
Show all 12Show fewer
- patients with cerebrovascular accident within 6 months prior to entry the study
- significant endocrine, hepatic or renal, disorders
- local or systemic infectious disease within 4 weeks prior to entry into study
- pregnancy or lactation
- mental instability
- Federal Medical Center inmates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Coronary Plaque Composition Using Optical Coherence Tomography During Chronic Inhibition of Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity
The investigator's hypothesis is that local activation of the endogenous Lp-PLA2 plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. Thus, the investigators study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the Lp-PLA2 pathway.
Read the detailed description
The present study was a substudy of our National Institute of Health (NIH) funded and Institutional Review Board (IRB) approved (08-008161) protocol "Lp-PLA2 and Coronary Atherosclerosis in Humans" and (10-000044) "Lp-PLA2 and Coronary Atherosclerosis in Humans Aim III" in which the investigators are examining the impact of long-term inhibition of Lp-PLA2, with a specific novel inhibitor, on Lp-PLA2 activity and improvement in coronary endothelial function.
This substudy will use Optical Coherence Tomography (OCT) to quantify alternate features of plaque vulnerability including superficial microcalcification, fibrous cap thickness, and plaque macrophage content at baseline and again at 6 months following Lp-PLA2 inhibition.
The study will provide insight into the role of the endogenous Lp-PLA2 in early coronary atherosclerosis, a potential therapeutic target for early coronary atherosclerosis in humans.
- Being tested
- Optical Coherence Tomography (C7 XR Dragonfly )
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography (C7 XR Dragonfly )Device
Also called C7 XR Dragonfly Optical Coherence Tomography system
Evaluation of the coronary artery using Optical Coherence Tomography utilizing the Dragonfly OCT catheter following a clinically indicated angiogram and endothelial function testing with a positive diagnosis of endothelial dysfunction. The procedure is repeated following 6 months of Lp-PLa2 inhibition or placebo.
| Study group | Role | What they receive |
|---|---|---|
| OCT at baseline | Other | Subjects enrolled in the NIH funded and IRB approved (08-008161) protocol "Lp-PLA2 and Coronary Atherosclerosis in Humans" with a positive diagnosis of coronary artery endothelial dysfunction will be studied using Optical Coherence Tomography during the angiogram at baseline. Receives: Device: Optical Coherence Tomography (C7 XR Dragonfly ) |
| OCT following 6 month Lp-PLa2 inhibition | Other | Subjects who are enrolled in IRB 10-000044 "Lp-PLA2 and Coronary Atherosclerosis in Humans Aim III" a study in which the investigators are examining the impact of long-term inhibition of Lp-PLA2, with a specific novel inhibitor or placebo, on Lp-PLA2 activity and improvement in coronary endothelial function will be studied using Optical Coherence Tomography during the 6 month return angiogram. Receives: Device: Optical Coherence Tomography (C7 XR Dragonfly ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of plaque vulnerability.
Following recruitment of the total study population and 6-months therapy with the Lp-PLA2 inhibitor or placebo, using Optical Coherence Tomography (OCT) we will quantify alternate features of plaque vulnerability including superficial microcalcification, fibrous cap thickness, and plaque macrophage content comparing baseline and 6 months studies.
Measured: change from baseline to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startOct 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Rajiv Gulati, Mayo Clinic
- Investigators
- Rajiv Gulati, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642173
- Sponsor's protocol ID
- 10-005460
- Status last verified
- Sep 2016
- First submitted
- 26 Jun 2012
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coronary Plaque Composition Using Optical Coherence Tomography During Chronic Inhibition of Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity
- ClinicalTrials.gov ID
- NCT01642173
- Acronym / sponsor ID
- 10-005460
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Oct 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Jul 2012 (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 investigator's hypothesis is that local activation of the endogenous Lp-PLA2 plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. Thus, the investigators study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the Lp-PLA2 pathway.
Detailed description
The present study was a substudy of our National Institute of Health (NIH) funded and Institutional Review Board (IRB) approved (08-008161) protocol "Lp-PLA2 and Coronary Atherosclerosis in Humans" and (10-000044) "Lp-PLA2 and Coronary Atherosclerosis in Humans Aim III" in which the investigators are examining the impact of long-term inhibition of Lp-PLA2, with a specific novel inhibitor, on Lp-PLA2 activity and improvement in coronary endothelial function.
This substudy will use Optical Coherence Tomography (OCT) to quantify alternate features of plaque vulnerability including superficial microcalcification, fibrous cap thickness, and plaque macrophage content at baseline and again at 6 months following Lp-PLA2 inhibition.
The study will provide insight into the role of the endogenous Lp-PLA2 in early coronary atherosclerosis, a potential therapeutic target for early coronary atherosclerosis in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT at baseline | Other | Device: Optical Coherence Tomography (C7 XR Dragonfly )Subjects enrolled in the NIH funded and IRB approved (08-008161) protocol "Lp-PLA2 and Coronary Atherosclerosis in Humans" with a positive diagnosis of coronary artery endothelial dysfunction will be studied using Optical Coherence Tomography during the angiogram at baseline. |
| OCT following 6 month Lp-PLa2 inhibition | Other | Device: Optical Coherence Tomography (C7 XR Dragonfly )Subjects who are enrolled in IRB 10-000044 "Lp-PLA2 and Coronary Atherosclerosis in Humans Aim III" a study in which the investigators are examining the impact of long-term inhibition of Lp-PLA2, with a specific novel inhibitor or placebo, on Lp-PLA2 activity and improvement in coronary endothelial function will be studied using Optical Coherence Tomography during the 6 month return angiogram. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years and < 85 years
- referred to our cardiac catheterization laboratory for coronary vasomotion testing
- are found to have coronary endothelial dysfunction.
Key exclusion criteria (12 listed)
- these include heart failure
- ejection fraction < 40%
- unstable angina
- myocardial infarction or angioplasty within 6 months prior to entry into the study
- use of investigational agents within 1 month of entry into the study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence Tomography (C7 XR Dragonfly )Also: C7 XR Dragonfly Optical Coherence Tomography systemEvaluation of the coronary artery using Optical Coherence Tomography utilizing the Dragonfly OCT catheter following a clinically indicated angiogram and endothelial function testing with a positive diagnosis of endothelial dysfunction. The procedure is repeated following 6 months of Lp-PLa2 inhibition or placebo. | Device | OCT at baseline, OCT following 6 month Lp-PLa2 inhibition |
Primary outcome
Quantification of plaque vulnerability.
Time frame: change from baseline to six months
Following recruitment of the total study population and 6-months therapy with the Lp-PLA2 inhibitor or placebo, using Optical Coherence Tomography (OCT) we will quantify alternate features of plaque vulnerability including superficial microcalcification, fibrous cap thickness, and plaque macrophage content comparing baseline and 6 months studies.
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 3 Oct 2016.
Related trials for Coronary Atherosclerosis
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
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.
Rajiv Gulati, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Optical Coherence Tomography (C7 XR Dragonfly ) in people with Coronary Atherosclerosis and Endothelial Dysfunction, run by Mayo Clinic 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 12 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 3 Oct 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quantification of plaque vulnerability. (time frame: change from baseline to six 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 3 Oct 2016.