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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02745821
• Other study ID #: 20150876
• Status: Terminated
• Phase: N/A
• Start date: June 2016
• Est. completion date: September 2022

Study information

• Verified date: January 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Duration of procedure in the catheterization laboratory ie 1 day
Secondary	Change in FFR in target vessel	FFR will be measured pre and post PCI of target vessel	Baseline and post PCI
Secondary	Change in CFR in target vessel	CFR will be measured pre and post PCI of target vessel	Baseline and post PCI
Secondary	Change in index of microvascular resistance (IMR) in target vessel	IMR will be measured pre and post PCI of target vessel	Baseline and post PCI