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

NCT02601664 | Terminated Phase 4 DMC

• 1 other identifier: 14-083
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Reduction of the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution

  18-24 hours post-procedure

Secondary Outcomes (3)

• Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB

  18-24 hours post-procedure

• Reduction in the incidence of slow flow/no-reflow post PCI

  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

  30 days

Study Arms (2)

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

Procedure: Combined Intervention

Conventional PCI

ACTIVE COMPARATOR

Conventional PCI

Procedure: Conventional PCI

Interventions

Combined Intervention PROCEDURE

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

Combined Intervention

Conventional PCI PROCEDURE

Conventional PCI

Conventional PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead

Related 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.

  PMID: 22511587 BACKGROUND

• 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.

  PMID: 21575750 BACKGROUND

• 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. No abstract available.

  PMID: 24254480 BACKGROUND

• 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.

  PMID: 26003018 BACKGROUND

• Erlinge 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.

  PMID: 25266075 BACKGROUND

MeSH Terms

Conditions

Arteriosclerosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Study Officials

• Emmanouil S Brilakis, MD, PhD

  North Texas Veterans Healthcare System

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiac Catheterization Laboratories, Professor of Medicine

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 10, 2015
• Study Start: November 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 29, 2016

Record last verified: 2016-06