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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

This study has been terminated.
Sponsor:
Information provided by:
North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01288105
First received: January 20, 2011
Last updated: December 27, 2011
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Coronary Stent Occlusion
Device: Optical coherence tomography
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Use of Optical Coherence Tomography to Determine the Optimal Management of Patients With Drug-eluting Stents Who Need Non-cardiac Surgery

Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 30-days post surgery ] [ Designated as safety issue: Yes ]
    composite of cardiac death, myocardial infarction, coronary revascularization


Estimated Enrollment: 107
Study Start Date: January 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Optical Coherence Tomography
Patients enrolled in the study will undergo optical coherence tomography to evaluate the extent of stent strut coverage.
Device: 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.
Other Name: invasive intracoronary imaging

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288105

Locations
United States, Texas
VA North Texas Healthcare System
Dallas, Texas, United States, 75216
Sponsors and Collaborators
North Texas Veterans Healthcare System
Investigators
Principal Investigator: Emmanouil S Brilakis, MD, PhD North Texas Veterans Healthcare System
  More Information

No publications provided

Responsible Party: Teresa D. Moore, IRB administrator, VA North Texas Healthcare System
ClinicalTrials.gov Identifier: NCT01288105     History of Changes
Other Study ID Numbers: 10-106
Study First Received: January 20, 2011
Last Updated: December 27, 2011
Health Authority: United States: Federal Government

Keywords provided by North Texas Veterans Healthcare System:
drug-eluting stents
noncardiac surgery

ClinicalTrials.gov processed this record on November 24, 2014