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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    50
  • sponsor
    Ottawa Heart Institute Research Corporation
Updated on 10 May 2022
stenosis
diabetes mellitus
angina pectoris
ischemia
coronary artery stenosis
arterial disease

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).

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.

Details
Condition Diabetes Mellitus, Coronary Artery Disease
Treatment Pressure Wire Certus, St. Jude Medical, USA
Clinical Study IdentifierNCT02745821
SponsorOttawa Heart Institute Research Corporation
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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