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

NCT ID: NCT02745821

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2022-09-30

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.

Conditions

Diabetes Mellitus; Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pressure Wire Certus, St. Jude Medical, USA

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aun-Yeong Chong, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

References

Curzen N, Rana O, Nicholas Z, Golledge P, Zaman A, Oldroyd K, Hanratty C, Banning A, Wheatcroft S, Hobson A, Chitkara K, Hildick-Smith D, McKenzie D, Calver A, Dimitrov BD, Corbett S. Does routine pressure wire assessment influence management strategy at coronary angiography for diagnosis of chest pain?: the RIPCORD study. Circ Cardiovasc Interv. 2014 Apr;7(2):248-55. doi: 10.1161/CIRCINTERVENTIONS.113.000978. Epub 2014 Mar 18.

Reference Type: BACKGROUND

PMID: 24642999 (View on PubMed)

Echavarria-Pinto M, Escaned J, Macias E, Medina M, Gonzalo N, Petraco R, Sen S, Jimenez-Quevedo P, Hernandez R, Mila R, Ibanez B, Nunez-Gil IJ, Fernandez C, Alfonso F, Banuelos C, Garcia E, Davies J, Fernandez-Ortiz A, Macaya C. Disturbed coronary hemodynamics in vessels with intermediate stenoses evaluated with fractional flow reserve: a combined analysis of epicardial and microcirculatory involvement in ischemic heart disease. Circulation. 2013 Dec 17;128(24):2557-66. doi: 10.1161/CIRCULATIONAHA.112.001345. Epub 2013 Oct 18.

Reference Type: BACKGROUND

PMID: 24141255 (View on PubMed)

Other Identifiers

20150876

Identifier Type: -

Identifier Source: org_study_id