Recruiting

PCI

Sponsor:

University of Saskatchewan

Code:

NCT01867034

Conditions

Acute Coronary Syndrome

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Drug Eluting Stent

Bare Metal Stent

Study Details

Brief summary:

It is hypothesized that patients with low pre-PCI serum levels of sRAGE should receive DES implantation and/ or procedures taken to increase serum levels of sRAGE and/ or decrease the serum levels of AGE.

The purpose of this pilot study is to afford invasive cardiologists with additional evidenced based information to guide their decision as to which patients should receive a BMS or DES for coronary implantation.

The objectives of the study are to determine whether or not:

1. Patients with low pre-PCI serum levels of sRAGE who receive bare metal stents develop restenosis
2. Patients with high pre-PCI serum levels of sRAGE who receive bare metal stents will have reduced risk of the development of restenosis
3. Patients with low pre-PCI serum levels of sRAGE who receive drug eluting stents will have an increased risk of the development of restenosis

Conditions

Acute Coronary Syndrome

Study ID

NCT01867034

Start date

Mar, 2013

Status verified date

Mar, 2012

Completion date

Jun, 2015

Anticipated

Primary completion date

Mar, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with NSTEMI
  • Discrete denovo localized lesions in single or multiple vessel
  • Non-diabetic
  • EF> 40%
  • Patients willing to come back for a follow-up angiogram 6 months post -PCI

Exclusion Criteria:

  • The reference diameter artery less than 2.5 mm in diameter
  • STEMI
  • Post-coronary artery bypass graft surgery
  • Diabetic
  • Coexisting inflammatory diseases
  • Coexisting valvular disease
  • Patients with a history of substance abuse

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Bare Metal stent

Stent that has not been impregnated with an anti-restenotic drug

active comparator: Drug Eluting Stent

Stent that has been impregnated with an anti-restenotic drug

Interventions

Drug Eluting Stent

Comparison of two stents to see which results in best outcome.

Bare Metal Stent

Primary outcome measure

  • sRAGE [ Time Frame: 6-months ]

Central Contacts and Locations

Central contacts

Erick D. McNair, PhD

306 222-7403erick.mcnair@usask.ca

Kailash Prasad, MD, PhD

306 966-6539kailash.prasad@usask.ca

Locations

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

Erick McNair, PhD

306 222-7403erick.mcnair@usask.ca

Kailash Prasad, MD,PhD

306 966-6539kailash.prasad@usask.ca

More Information

Sponsor

University of Saskatchewan

Last update posted

Jun 3, 2013

Last verified

Mar, 2012

Keywords

  • non ST segment myocardial infarction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2013-06-03.