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Coronary Physiology and Its Relationship to Anatomy in Patients With Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02745821
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE April 4, 2016
First Posted Date  ICMJE April 20, 2016
Last Update Posted Date March 25, 2020
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
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. [ Time Frame: Duration of procedure in the catheterization laboratory ie 1 day ]
This is primarily an observational pilot study where coronary physiology is obtained at the time of the percutaneous coronary intervention (PCI) of the target vessel.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • Change in FFR in target vessel [ Time Frame: Baseline and post PCI ]
    FFR will be measured pre and post PCI of target vessel
  • Change in CFR in target vessel [ Time Frame: Baseline and post PCI ]
    CFR will be measured pre and post PCI of target vessel
  • Change in index of microvascular resistance (IMR) in target vessel [ Time Frame: Baseline and post PCI ]
    IMR will be measured pre and post PCI of target vessel
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coronary Physiology and Its Relationship to Anatomy in Patients With Diabetes Mellitus
Official Title  ICMJE Coronary Physiology and Its Relationship to Anatomy in Patients With Diabetes Mellitus
Brief Summary Comprehensive assessment of coronary physiology (fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR)) in patients with diabetes mellitus and coronary artery disease (CAD).
Detailed Description

Background:

There is currently no data on invasive measurement of FFR, CFR and IMR in patients with diabetes mellitus. Studies such as RIPCORD has shown that using coronary angiography alone to guide revascularization strategy may be flawed in a significant proportion of patients.

Patients with diabetes mellitus are more likely to have diffuse CAD and microvascular disease. Current recommendation of invasive physiological assessment to guide percutaneous coronary intervention (PCI) is limited to FFR alone. This can be misleading in diffuse coronary artery disease and microvascular disease as both conditions are associated with higher FFR. The proportion of vessels which show discordance between FFR and CFR consistent with diffuse CAD and/or microvascular disease in patients has been shown to be as high as 30% in a study not exclusive to diabetics.

This is a pilot study of 50 patients referred for PCI based on angiographic stenosis of ≥50%. Comprehensive physiological assessment will be undertaken in target and non-target vessels to determine the prevalence of discordant FFR and CFR consistent with diffuse CAD and/or microvascular dysfunction in diabetics.

Methods:

  1. Patients will receive an information sheet after initial invitation to participate in the study.
  2. Written informed consent will be obtained.
  3. Patients will undergo invasive assessment of FFR, CFR and IMR in non-target vessels.
  4. An optical coherence tomography (OCT) study will be performed to correlate physiological parameters with intravascular imaging for diffuse atheromatous disease.
  5. Patients will then undergo OCT and invasive assessment of FFR, CFR and IMR in the target vessel pre and post PCI.
  6. Any change in FFR, CFR and IMR post PCI will be recorded.
  7. All physiological parameters will be measured using the pressure wire from St. Jude Medical, USA (currently, Certus). Results will be grouped according to 4 possible permutations of FFR and CFR.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Diabetes Mellitus
  • Coronary Artery Disease
Intervention  ICMJE Device: Pressure Wire Certus, St. Jude Medical, USA
FFR. CFR and IMR will be measured using the Pressure Wire Certus, St. Jude Medical, USA in target and non-target vessels. Changes in FFR, CFR and IMR post PCI of target vessels will also be recorded.
Study Arms  ICMJE Experimental: Coronary physiology
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.
Intervention: Device: Pressure Wire Certus, St. Jude Medical, USA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diabetic patients with angina and/or evidence of myocardial ischemia (includes ACS patients but not STEMI)
  • Willing and able to provide informed, written consent
  • Diabetic patients with clinically indicated, abnormal PET scan
  • Single or double vessel disease with coronary stenosis ≥50% referred for PCI

Exclusion Criteria:

  • Significant left main stenosis ≥50% and/or triple vessel disease referred for CABG
  • Recent STEMI (<5 days)
  • Previous CABG
  • LVEF ≤ 30% or cardiogenic shock
  • Complex coronary anatomy preventing FFR/CFR measurement
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Poppy MacPhee 613 6967000 ext 14646 pmacphee@ottawaheart.ca
Contact: Carol Mitchell 613 6967000 ext 14646 cmitchell@ottawaheart.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02745821
Other Study ID Numbers  ICMJE 20150876
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ottawa Heart Institute Research Corporation
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aun-Yeong Chong, MD Ottawa Heart Institute Research Corporation
PRS Account Ottawa Heart Institute Research Corporation
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP