The Association Between Platelet Inhibition and Perioperative Major Adverse Cardiac Events In Post-Percutaneous Coronary Intervention (PCI) Patients Undergoing Non-Cardiac Surgery

NCT01707459 | Completed

• 1 other identifier: UHN090090BE
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, multicentre, observational study aims to test pre-operative platelet function when taking anti-platelet medications. The investigators are using a simple bedside blood test called Thromboelastography (TEG) and Platelet Mapping Assay (PMA). The investigators will then follow the patient throughout their hospital stay for any major cardiac complications (MACE) after surgery (peri-operative). The investigators hope to determine if there is an association between how well platelets were inhibited by these drugs before surgery and MACE during the perioperative period, 30 day, and one year follow-up. Also, the response of various people to anti-platelet medications and their chances of getting a major adverse cardiac outcome are determined by their genetic makeup. The investigators will try to determine if certain genes are associated with higher cardiac risk. Hypothesis: In patients who had percutaneous coronary intervention (PCI) and are undergoing non-cardiac surgery (NCS) major adverse cardiac events (MACE) are associated with inadequate platelet inhibition.

Conditions

Thrombosis

Keywords

platelet function; perioperative complications; major adverse cardiac events (MACE); thromboelastography; polymorphism analysis; coronary stents; non-cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Number of patients with major adverse cardiac event (MACE)

  ECG daily for five days postoperatively Troponin measurements every 8 h +/- 1h for 6 measurements (first 48 hours postoperatively) then once daily till the fifth postoperative day. Patients will be assessed daily by study personnel for the presence of MACE (defined as death, ST or non-ST elevation myocardial infarction \[MI\], stent thrombosis or the need for repeat revascularization \[PCI or coronary artery bypass grafting\]transfusions, or the presence of bleeding complications.

  Measure will occure every day for 5 postoperative days

Eligibility Criteria

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

Study Population

Patients who have coronary stents and undergoing non-cardiac surgery

You may qualify if:

• Scheduled for non-cardiac surgery
• Has had PCI with: BMS within the last 24 months OR DES within any time frame

You may not qualify if:

• Lack of informed consent
• Known clotting abnormality affecting any part of the clotting cascade
• Liver dysfunction with co-existing thrombocytopenia or INR \> 1.4

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Anesthesia Patient Safety Foundation: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, Canada

Location

Related Publications (1)

• Wasowicz M, Syed S, Wijeysundera DN, Starzyk L, Grewal D, Ragoonanan T, Harsha P, Travis G, Carroll J, Karkouti K, Beattie WS. Effectiveness of platelet inhibition on major adverse cardiac events in non-cardiac surgery after percutaneous coronary intervention: a prospective cohort study. Br J Anaesth. 2016 Apr;116(4):493-500. doi: 10.1093/bja/aev556. Epub 2016 Feb 16.

  PMID: 26888800 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

TEG-PMA and gene polymorphism analysis on blood samples

MeSH Terms

Conditions

Thrombosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases

Study Officials

• Marcin Wasowicz, MD

  Toronto General Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: October 16, 2012
• Study Start: March 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2014
• Last Updated: June 18, 2015

Record last verified: 2015-06

Locations

CA (1)