NCT02745821

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

6.3 years

First QC Date

April 4, 2016

Last Update Submit

January 12, 2023

Conditions

Diabetes MellitusCoronary Artery Disease

Keywords

coronary flow reservefractional flow reservediabetes mellituscoronary artery diseasepercutaneous coronary interventioncoronary physiologyindex of microcirculatory resistance

Outcome Measures

Primary Outcomes (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.

    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 Outcomes (3)

  • Change in FFR in target vessel

    Baseline and post PCI

  • Change in CFR in target vessel

    Baseline and post PCI

  • Change in index of microvascular resistance (IMR) in target vessel

    Baseline and post PCI

Study Arms (1)

Coronary physiology

EXPERIMENTAL

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

Interventions

Pressure Wire Certus, St. Jude Medical, USADEVICE

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.

Coronary physiology

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related 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.

    PMID: 24642999BACKGROUND

  • 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.

    PMID: 24141255BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusCoronary Artery Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Aun-Yeong Chong, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 20, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Locations

CA(1)