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Pressure Wire Certus, St. Jude Medical, USA for Diabetes

N/A
Waitlist Available
Led By Aun-Yeong Chong, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post pci
Awards & highlights

Summary

This trial assesses three measures of heart function in patients with diabetes and CAD.

Eligible Conditions
  • Diabetes
  • Coronary Artery Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of procedure in the catheterization laboratory ie 1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of procedure in the catheterization laboratory ie 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prevalence of number of vessels fulfilling each of 4 permutations of fractional flow reserve (FFR) and coronary flow reserve (CFR) ie FFR ≤0.80 CFR ≥2.0, FFR ≤0.80 CFR <2.0, FFR >0.80 CFR ≥2.0 and FFR >0.80 CFR <2.0.
Secondary outcome measures
Change in CFR in target vessel
Change in FFR in target vessel
Change in index of microvascular resistance (IMR) in target vessel

Trial Design

1Treatment groups
Experimental Treatment
Group I: Coronary physiologyExperimental Treatment1 Intervention
Non-target and target vessels of patients with diabetes mellitus referred for PCI will be assessed for FFR, CFR and IMR. Intravenous adenosine at 140 micrograms/kg/min will be used to induce maximal hyperemia.

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Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
189 Previous Clinical Trials
92,311 Total Patients Enrolled
3 Trials studying Diabetes
329 Patients Enrolled for Diabetes
Aun-Yeong Chong, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
~1 spots leftby Jul 2025
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