Randomized-controlled Trial of a Combined vs. Conventional Percutaneous Intervention for Near-Infrared Spectroscopy Defined High-Risk Native Coronary Artery Lesions

Coronary Artery Disease Clinical Trial

— CONCERTO  

Official title:

Randomized-controlled Trial of a Combined vs. Conventional Percutaneous Intervention for Near-Infrared Spectroscopy Defined High-Risk Native Coronary Artery Lesions

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02601664
• Other study ID #: 14-083
• Status: Terminated
• Phase: Phase 4
• First received: November 6, 2015
• Last updated: June 27, 2016
• Start date: November 2015
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Board ReviewUnited States: Federal GovernmentUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years.

2. Willing and able to provide informed consent and able to comply with study procedures and follow-up.

3. Undergoing a clinically indicated left heart coronary catheterization

4. 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.

Exclusion Criteria:

1. Coexisting conditions that limit life expectancy to less than 30-days or that could affect the patient's compliance with the protocol.

2. Positive pregnancy test or breast-feeding.

3. High risk for bleeding.

4. Subject is currently, or within the 30 preceding days, participating in a device or pharmaceutical treatment protocol.

5. Clinical presentation with ST-segment elevation MI.

6. Persistent (>10 minutes) hypotension (systolic blood pressure <90 mmHg)

7. Need for revascularization of multiple lesions during the index PCI.

8. Unprotected left main (>50%) or equivalent left main disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Infarction
• Myocardial Ischemia
• Near-infrared Spectroscopy
• Peri-procedural Myocardial Infarction

Intervention

Procedure:
• Combined Intervention
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 PCI
Conventional PCI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

References & Publications (5)

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. — View Citation

Erlinge D, Harnek J, Gonçalves I, Götberg 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. — View Citation

Patel 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. Review. — View Citation

Raghunathan 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. — View Citation

Stone 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution		18-24 hours post-procedure	No
Secondary	Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB		18-24 hours post-procedure	No
Secondary	Reduction in the incidence of slow flow/no-reflow post PCI		2-3 hours after	No
Secondary	Lower incidence of major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during 30-day follow-up		30 days	No