Soluble Receptors for Advanced Glycation End-Products and PCI
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 29, 2013
CompletedFirst Posted
Study publicly available on registry
June 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJune 3, 2013
March 1, 2012
2 years
May 29, 2013
May 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sRAGE
The serum levels of sRAGE will be determined at six months.
6-months
Secondary Outcomes (1)
coronary restenosis
6-months
Study Arms (2)
Bare Metal stent
ACTIVE COMPARATORStent that has not been impregnated with an anti-restenotic drug
Drug Eluting Stent
ACTIVE COMPARATORStent that has been impregnated with an anti-restenotic drug
Interventions
Comparison of two stents to see which results in best outcome.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erick McNair, PhD
University of Saskatchewan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2013
First Posted
June 3, 2013
Study Start
March 1, 2013
Primary Completion
March 1, 2015
Study Completion
June 1, 2015
Last Updated
June 3, 2013
Record last verified: 2012-03