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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 : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Coronary Artery Disease Device: Pressure Wire Certus, St. Jude Medical, USA Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Coronary Physiology and Its Relationship to Anatomy in Patients With Diabetes Mellitus
Study Start Date : June 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in FFR in target vessel [ Time Frame: Baseline and post PCI ]
    FFR will be measured pre and post PCI of target vessel

  2. Change in CFR in target vessel [ Time Frame: Baseline and post PCI ]
    CFR will be measured pre and post PCI of target vessel

  3. 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



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745821


Contacts
Contact: Lyne Stuewe 613 6967000 ext 14646 lstuewe@ottawaheart.ca
Contact: Colleen Chilton 613 6967000 ext 14646 cchilton@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Colleen Chilton    613 6967000 ext 14646    cchilton@ottawaheart.ca   
Contact: Lyne Stuewe    613 6967000 ext 14646    lstuewe@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: Aun-Yeong Chong, MD Ottawa Heart Institute Research Corporation

Publications:
Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02745821     History of Changes
Other Study ID Numbers: 20150876
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by Ottawa Heart Institute Research Corporation:
coronary flow reserve
fractional flow reserve
diabetes mellitus
coronary artery disease
percutaneous coronary intervention
coronary physiology
index of microcirculatory resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases