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

Not Applicable

Terminated

• Conditions: Diabetes Mellitus; Coronary Artery Disease
• Interventions: Device: Pressure Wire Certus, St. Jude Medical, USA

• Registration Number: NCT02745821
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-20
• Study Start: 2016-06
• Primary Completion: 2022-09
• Study Completion: 2022-09
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronary physiology	Pressure Wire Certus, St. Jude Medical, USA	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.

Primary Outcome Measures

Name	Time	Method
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.	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

Name	Time	Method
Change in FFR in target vessel	Baseline and post PCI	FFR will be measured pre and post PCI of target vessel
Change in index of microvascular resistance (IMR) in target vessel	Baseline and post PCI	IMR will be measured pre and post PCI of target vessel
Change in CFR in target vessel	Baseline and post PCI	CFR will be measured pre and post PCI of target vessel

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada