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

NCT ID: NCT01288105

Last Updated: 2011-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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.

Conditions

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Coronary Stent Occlusion

Keywords

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drug-eluting stents noncardiac surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Optical Coherence Tomography

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

Group Type EXPERIMENTAL

Optical coherence tomography

Intervention Type 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.

Interventions

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Optical coherence tomography

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.

Intervention Type DEVICE

Other Intervention Names

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invasive intracoronary imaging

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Texas Veterans Healthcare System

FED

Sponsor Role lead

Responsible Party

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VA North Texas Healthcare System

Principal Investigators

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Emmanouil S Brilakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

North Texas Veterans Healthcare System

Locations

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VA North Texas Healthcare System

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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10-106

Identifier Type: -

Identifier Source: org_study_id