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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
Diabetic patients with angina and/or evidence of myocardial ischemia (includes ACS patients but not STEMI)
Willing and able to provide informed, written consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post pci
Awards & highlights

Study Summary

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

Eligible Conditions
  • Diabetes
  • Coronary Artery Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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.

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,564 Total Patients Enrolled
3 Trials studying Diabetes
329 Patients Enrolled for Diabetes
Aun-Yeong Chong, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available opportunities for people to sign up for this medical trial?

"Affirmative. According to information on clinicaltrials.gov, this trial is actively recruiting patients who were initially posted in the database on June 1st 2016 and last updated April 25th 2022. The team managing the study are looking for 50 participants at a single medical facility."

Answered by AI

Is participation in this medical experiment open to me?

"To be accepted into this clinical research, participants must have diabetes mellitus and fall between the ages of 21 to 75. A total of 50 volunteers are required for successful completion."

Answered by AI

Is the age limit of this experiment limited to adults only?

"To be eligible for this trial, participants must fall within the age range of 21 to 75 years. Alternatively, there are 208 studies that can serve minors and 1,432 trials accessible to seniors beyond 65."

Answered by AI

How many individuals are currently involved in this clinical experiment?

"Yes, according to the details available on clinicaltrials.gov this research is actively recruiting participants. It was first posted in June of 2016 and most recently updated on April 25th 2022, with a desire for 50 subjects across only one site."

Answered by AI
Recent research and studies
~1 spots leftby Apr 2025