ArteriosclerosisPhase 4CONCERTONCT02601664
Randomized-controlled Trial of a Combined vs. Conventional Percutaneous Intervention for Near-Infrared Spectroscopy Defined High-Risk Native Coronary Artery Lesions
A Phase 4 study testing Combined Intervention and Conventional PCI in people with Arteriosclerosis and Near-infrared Spectroscopy, run by North Texas Veterans Healthcare System.
Trial summary
Design: Single center, single-blind randomized controlled trial of patients with high risk native coronary artery lesions (defined as ≥2 contiguous yellow blocks on the block chemogram) requiring clinically indicated percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriosclerosis, Near-infrared Spectroscopy, Peri-procedural Myocardial Infarction
- What is being tested?
- Combined Intervention and Conventional PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Feb 2016
- Phase
- Phase 4
- 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
Who may be able to join
- Age ≥18 years.
- Willing and able to provide informed consent and able to comply with study procedures and follow-up.
- Undergoing a clinically indicated left heart coronary catheterization
- Need PCI of a high-risk native coronary artery lesion. High-risk lesions will be defined as lesions with ≥2 contiguous yellow blocks on block chemogram.
Who cannot join
- Coexisting conditions that limit life expectancy to less than 30-days or that could affect the patient's compliance with the protocol.
- Positive pregnancy test or breast-feeding.
- High risk for bleeding.
- Subject is currently, or within the 30 preceding days, participating in a device or pharmaceutical treatment protocol.
- Clinical presentation with ST-segment elevation MI.
- Persistent (>10 minutes) hypotension (systolic blood pressure <90 mmHg)
- Need for revascularization of multiple lesions during the index PCI.
- Unprotected left main (>50%) or equivalent left main disease.
About this study
Design: Single center, single-blind randomized controlled trial of patients with high risk native coronary artery lesions (defined as ≥2 contiguous yellow blocks on the block chemogram) requiring clinically indicated percutaneous coronary intervention. Patients will be randomized to either a combined intervention or conventional PCI. Cardiac biomarker measurements will be performed before PCI and 18-24 hours later.
Treatment: Combined intervention consisting of pre-PCI intracoronary vasodilator and glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and complete coverage of the lipid core plaque, if technically feasible.
Read more
Control: Conventional PCI. Duration: 30 days follow-up. The primary trial objective is to compare the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution in the two study groups.
The secondary endpoints are: (1) Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB. (2) Reduction in the incidence of slow flow/no-reflow post PCI. (3) Lower incidence of major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during 30-day follow-up.
- Conditions
- Arteriosclerosis, Near-infrared Spectroscopy, Peri-procedural Myocardial Infarction, Coronary Artery Disease
- Being tested
- Combined Intervention, Conventional PCI
- Medical subject headings
- Arteriosclerosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined InterventionProcedure or surgery
pre-PCI intracoronary vasodilator administration and glycoprotein IIb/IIIa inhibitor administration, use of an embolization protection device if technically feasible, and complete coverage of the lipid core plaque, if technically feasible
Conventional PCIProcedure or surgery
Conventional PCI
| Study group | Role | What they receive |
|---|---|---|
| Combined Intervention | Active comparator | Combined intervention: pre-PCI intracoronary vasodilator and glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and complete coverage of the lipid core plaque, if technically feasible Receives: Procedure: Combined Intervention |
| Conventional PCI | Active comparator | Conventional PCI Receives: Procedure: Conventional PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution
Measured: 18-24 hours post-procedure
Secondary outcomes (3)
Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB
Measured: 18-24 hours post-procedure
Reduction in the incidence of slow flow/no-reflow post PCI
Measured: 2-3 hours after
Lower incidence of major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during 30-day follow-up
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2016
- Study completionFeb 2016
Why it stopped: Due to lack of eligible patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ArteriosclerosisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Emmanouil Brilakis, North Texas Veterans Healthcare System
- Investigators
- Emmanouil S Brilakis, MD, PhD, Study chair, North Texas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601664
- Sponsor's protocol ID
- 14-083
- Acronym
- CONCERTO
- Status last verified
- Jun 2016
- First submitted
- 6 Nov 2015
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brilakis ES, Abdel-Karim AR, Papayannis AC, Michael TT, Rangan BV, Johnson JL, Banerjee S. Embolic protection device utilization during stenting of native coronary artery lesions with large lipid core plaques as detected by near-infrared spectroscopy. Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1157-62. doi: 10.1002/ccd.23507. Epub 2012 Apr 17.
PubMed 22511587Raghunathan D, Abdel-Karim AR, Papayannis AC, daSilva M, Jeroudi OM, Rangan BV, Banerjee S, Brilakis ES. Relation between the presence and extent of coronary lipid core plaques detected by near-infrared spectroscopy with postpercutaneous coronary intervention myocardial infarction. Am J Cardiol. 2011 Jun 1;107(11):1613-8. doi: 10.1016/j.amjcard.2011.01.044.
PubMed 21575750Patel VG, Brayton KM, Mintz GS, Maehara A, Banerjee S, Brilakis ES. Intracoronary and noninvasive imaging for prediction of distal embolization and periprocedural myocardial infarction during native coronary artery percutaneous intervention. Circ Cardiovasc Imaging. 2013 Nov;6(6):1102-14. doi: 10.1161/CIRCIMAGING.113.000448. No abstract available.
PubMed 24254480Stone GW, Maehara A, Muller JE, Rizik DG, Shunk KA, Ben-Yehuda O, Genereux P, Dressler O, Parvataneni R, Madden S, Shah P, Brilakis ES, Kini AS; CANARY Investigators. Plaque Characterization to Inform the Prediction and Prevention of Periprocedural Myocardial Infarction During Percutaneous Coronary Intervention: The CANARY Trial (Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow). JACC Cardiovasc Interv. 2015 Jun;8(7):927-36. doi: 10.1016/j.jcin.2015.01.032. Epub 2015 May 20.
PubMed 26003018Erlinge D, Harnek J, Goncalves I, Gotberg M, Muller JE, Madder RD. Coronary liposuction during percutaneous coronary intervention: evidence by near-infrared spectroscopy that aspiration reduces culprit lesion lipid content prior to stent placement. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):316-24. doi: 10.1093/ehjci/jeu180. Epub 2014 Sep 28.
PubMed 25266075
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-controlled Trial of a Combined vs. Conventional Percutaneous Intervention for Near-Infrared Spectroscopy Defined High-Risk Native Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT02601664
- Acronym / sponsor ID
- CONCERTO / 14-083
- Conditions
- Arteriosclerosis, Near-infrared Spectroscopy, Peri-procedural Myocardial Infarction, Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of eligible patients.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Nov 2015 (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.
Design: Single center, single-blind randomized controlled trial of patients with high risk native coronary artery lesions (defined as ≥2 contiguous yellow blocks on the block chemogram) requiring clinically indicated percutaneous coronary intervention. Patients will be randomized to either a combined intervention or conventional PCI. Cardiac biomarker measurements will be performed before PCI and 18-24 hours later.
Treatment: Combined intervention consisting of pre-PCI intracoronary vasodilator and glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and complete coverage of the lipid core plaque, if technically feasible.
Control: Conventional PCI. Duration: 30 days follow-up. The primary trial objective is to compare the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution in the two study groups.
The secondary endpoints are: (1) Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB. (2) Reduction in the incidence of slow flow/no-reflow post PCI. (3) Lower incidence of major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during 30-day follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Intervention | Active comparator | Procedure: Combined InterventionCombined intervention: pre-PCI intracoronary vasodilator and glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and complete coverage of the lipid core plaque, if technically feasible |
| Conventional PCI | Active comparator | Procedure: Conventional PCIConventional PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Willing and able to provide informed consent and able to comply with study procedures and follow-up.
- Undergoing a clinically indicated left heart coronary catheterization
- Need PCI of a high-risk native coronary artery lesion. High-risk lesions will be defined as lesions with ≥2 contiguous yellow blocks on block chemogram.
Key exclusion criteria (8 listed)
- Coexisting conditions that limit life expectancy to less than 30-days or that could affect the patient's compliance with the protocol.
- Positive pregnancy test or breast-feeding.
- High risk for bleeding.
- Subject is currently, or within the 30 preceding days, participating in a device or pharmaceutical treatment protocol.
- Clinical presentation with ST-segment elevation MI.
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 |
|---|---|---|
| Combined Interventionpre-PCI intracoronary vasodilator administration and glycoprotein IIb/IIIa inhibitor administration, use of an embolization protection device if technically feasible, and complete coverage of the lipid core plaque, if technically feasible | Procedure or surgery | Combined Intervention |
| Conventional PCIConventional PCI | Procedure or surgery | Conventional PCI |
Primary outcome
Reduction of the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution
Time frame: 18-24 hours post-procedure
3 secondary outcomes
Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB
Time frame: 18-24 hours post-procedure
Reduction in the incidence of slow flow/no-reflow post PCI
Time frame: 2-3 hours after
Lower incidence of major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during 30-day follow-up
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Due to lack of eligible patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Background: PubMed 22511587Brilakis ES, Abdel-Karim AR, Papayannis AC, Michael TT, Rangan BV, Johnson JL, Banerjee S. Embolic protection device utilization during stenting of native coronary artery lesions with large lipid core plaques as detected by near-infrared spectroscopy. Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1157-62. doi: 10.1002/ccd.23507. Epub 2012 Apr 17.
- Background: PubMed 21575750Raghunathan D, Abdel-Karim AR, Papayannis AC, daSilva M, Jeroudi OM, Rangan BV, Banerjee S, Brilakis ES. Relation between the presence and extent of coronary lipid core plaques detected by near-infrared spectroscopy with postpercutaneous coronary intervention myocardial infarction. Am J Cardiol. 2011 Jun 1;107(11):1613-8. doi: 10.1016/j.amjcard.2011.01.044.
- Background: PubMed 24254480Patel VG, Brayton KM, Mintz GS, Maehara A, Banerjee S, Brilakis ES. Intracoronary and noninvasive imaging for prediction of distal embolization and periprocedural myocardial infarction during native coronary artery percutaneous intervention. Circ Cardiovasc Imaging. 2013 Nov;6(6):1102-14. doi: 10.1161/CIRCIMAGING.113.000448. No abstract available.
- Background: PubMed 26003018Stone GW, Maehara A, Muller JE, Rizik DG, Shunk KA, Ben-Yehuda O, Genereux P, Dressler O, Parvataneni R, Madden S, Shah P, Brilakis ES, Kini AS; CANARY Investigators. Plaque Characterization to Inform the Prediction and Prevention of Periprocedural Myocardial Infarction During Percutaneous Coronary Intervention: The CANARY Trial (Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow). JACC Cardiovasc Interv. 2015 Jun;8(7):927-36. doi: 10.1016/j.jcin.2015.01.032. Epub 2015 May 20.
- Background: PubMed 25266075Erlinge D, Harnek J, Goncalves I, Gotberg M, Muller JE, Madder RD. Coronary liposuction during percutaneous coronary intervention: evidence by near-infrared spectroscopy that aspiration reduces culprit lesion lipid content prior to stent placement. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):316-24. doi: 10.1093/ehjci/jeu180. Epub 2014 Sep 28.
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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.
Emmanouil S Brilakis, MD, PhD study chair
North Texas Veterans Healthcare System
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combined Intervention and Conventional PCI in people with Arteriosclerosis and Near-infrared Spectroscopy, run by North Texas Veterans Healthcare System.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 29 Jun 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Due to lack of eligible patients.). Results are not available in the source record.
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?
Reduction of the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution (time frame: 18-24 hours post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02601664, which also lists 5 linked publications.
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 29 Jun 2016.