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Clinical Trials/NCT01288105
NCT01288105
Terminated
Phase 4

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

North Texas Veterans Healthcare System1 site in 1 country107 target enrollmentJanuary 2011

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Coronary Stent Occlusion
Sponsor
North Texas Veterans Healthcare System
Enrollment
107
Locations
1
Primary Endpoint
Major adverse cardiac events
Status
Terminated
Last Updated
14 years ago

Overview

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.

Detailed Description

Patients who receive drug-eluting stents (DES) and subsequently require non-cardiac surgery have increased risk for perioperative stent thrombosis, especially when antiplatelet therapy discontinuation is required. Perioperative administration of a glycoprotein IIb/IIIa inhibitor may decrease the stent thrombosis risk, but it is cumbersome and carries high cost. Stents that have been endothelialized by optical coherence tomography (OCT) are likely to have low risk for perioperative stent thrombosis and therefore intensive management strategies, such as "bridging with a glycoprotein IIb/IIIa inhibitor" would not be required. The current study will assess whether OCT utilization can help optimize the preoperative management of DES patients requiring major non-cardiac surgery. 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. The hypothesis is that OCT and IVUS-guided treatment will have low incidence (≤10%) of perioperative major adverse cardiac events. 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. The hypothesis is that OCT and IVUS-guided treatment will have low incidence (≤10%) of perioperative major adverse cardiac events.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
February 2014
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
North Texas Veterans Healthcare System

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older
  • Need for major non-cardiac surgery requiring discontinuation of dual antiplatelet therapy
  • Agree to participate and provide informed consent

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Major adverse cardiac events

Time Frame: 30-days post surgery

composite of cardiac death, myocardial infarction, coronary revascularization

Study Sites (1)

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