Use of Optical Coherence Tomography to Determine the Optimal Management of Patients With Drug-eluting Stents Who Need Non-cardiac Surgery

NCT01288105 | Terminated Phase 4

• 1 other identifier: 10-106
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aim of this proposal is to examine the impact of OCT and IVUS-guided management of patients with prior DES implantation who need major non-cardiac surgery and discontinuation of dual antiplatelet therapy on the perioperative (1 week prior to surgery until 30 days post surgery) incidence of major adverse cardiac events.

Conditions

Coronary Stent Occlusion

Keywords

drug-eluting stents; noncardiac surgery

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events

  composite of cardiac death, myocardial infarction, coronary revascularization

  30-days post surgery

Study Arms (1)

Optical Coherence Tomography

EXPERIMENTAL

Patients enrolled in the study will undergo optical coherence tomography to evaluate the extent of stent strut coverage.

Device: Optical coherence tomography

Interventions

Optical coherence tomography DEVICE

Optical coherence tomography will be performed to determine the stent strut coverage. Patients in whom \>95% of stent struts are covered will not receive perioperative bridging with a glycoprotein IIb/IIIa inhibitors, whereas those with \<95% stent strut coverage will receive perioperative bridging.

Also known as: invasive intracoronary imaging

Optical Coherence Tomography

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 or older
• Need for major non-cardiac surgery requiring discontinuation of dual antiplatelet therapy
• Agree to participate and provide informed consent

You may not qualify if:

• Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)
• Challenging vascular access
• History of an allergic reaction to glycoprotein IIb/IIIa inhibitors

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead

Study Sites (1)

VA North Texas Healthcare System

Dallas, Texas, 75216, United States

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Emmanouil S Brilakis, MD, PhD

  North Texas Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: February 2, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: December 28, 2011

Record last verified: 2010-12

Locations

US (1)