A Trial in Stable Intermediate Coronary Lesions and Grey-zone FFR Values
GzFFR
A Randomised Controlled Trial in Stable Intermediate Coronary Lesions and Grey-zone FFR Values With Evaluation of the Diagnostic Utility of Invasive Coronary Physiological Indices and Quantitative Perfusion MRI. The GzFFR Study
1 other identifier
interventional
108
1 country
1
Brief Summary
In this randomised controlled trial of patients with stable angina and documented intermediate coronary disease with indeterminate or "grey-zone" Fractional Flow Reserve (FFR) we will randomise patients to either optimal medical therapy alone versus optimal medical therapy with PCI and they will be followed up for the primary endpoint of anginal control as measured by the Seattle Angina Questionnaire at 3 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
1 active site
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
March 30, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedMarch 3, 2017
March 1, 2015
1.5 years
March 30, 2015
March 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Angina status as per Seattle Angina Questionnaire
Anginal severity as measured by the Seattle Angina Score at 3 months compared with baseline in patients randomized to PCI versus medical therapy.
3 months
Secondary Outcomes (4)
MACE
3 and 12 months
Myocardial infarction
3 and 12 months
Urgent Revascularisation
3 and 12 months
Total number of anti-anginal medications
3 and 12 months
Study Arms (2)
Optimal Medical Therapy
EXPERIMENTALPatients will receive secondary prevention and optimal medical therapy to control their anginal symptoms according to international guidelines without PCI of their grey-zone FFR lesion
PCI with Optimal Medical Therapy
ACTIVE COMPARATORPatients will undergo PCI of their grey-zone FFR lesion as well as appropriate secondary prevention. Anti-anginal therapy will be administered as per clinical requirements according to international guidelines.
Interventions
Patients will have balloon angioplasty and coronary stent insertion for their grey-zone FFR lesion.
Optimal Medical therapy consists of secondary prevention which will include high dose statin and aspirin as well as anti-anginal therapy according to ESC 2013 international treatment guidelines for stable angina as follows; B-Blocker or Calcium channel blocker as first line agents and Nicorandil or Nitrates or Ranolazine as second line treatment titrated against symptoms to maximum tolerated dose. ACE inhibitors or Angiotensin Receptor Blockers will be prescribed if patients also have a diagnosis of hypertension, LVEF ≤40%, diabetes or CKD where appropriate.
Eligibility Criteria
You may qualify if:
- Patients \>18 years
- % Diameter Stenosis on QCA
- Stable angina
- Non ST-elevation myocardial infarction (NSTEMI) with stable symptoms
- Able to provide informed consent
You may not qualify if:
- STEMI within 5 days
- Tortuous vessels which would render pressure wire studies difficult or impossible
- Heavily calcified vessels which would render pressure wire studies difficult or impossible
- Unstable symptoms requiring definitive interventional management
- Severe claustrophobia
- Age \>90 years
- Life expectancy \<1 year
- Estimated Glomerular Filtration Rate \<30 mls/min/1.73m2
- Inability to undergo MRI scanning due to metallic implant or incompatible permanent pacemaker
- Severe asthma or inability to safely receive an adenosine infusion
- Left mainstem disease ≤50% or if considered clinically significant by the operating cardiologist either on angiography or intravascular ultrasound.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Golden Jubilee National Hospitallead
- British Heart Foundationcollaborator
- University of Glasgowcollaborator
Study Sites (1)
Golden Jubilee National Hospital
Glasgow, Dunbartonshire, G81 4DY, United Kingdom
Related Publications (1)
Hennigan B, Berry C, Collison D, Corcoran D, Eteiba H, Good R, McEntegart M, Watkins S, McClure JD, Mangion K, Ford TJ, Petrie MC, Hood S, Rocchiccioli P, Shaukat A, Lindsay M, Oldroyd KG. Percutaneous coronary intervention versus medical therapy in patients with angina and grey-zone fractional flow reserve values: a randomised clinical trial. Heart. 2020 May;106(10):758-764. doi: 10.1136/heartjnl-2019-316075. Epub 2020 Feb 29.
PMID: 32114516DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keith G Oldroyd, M.D.
National Health Service
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2015
First Posted
April 24, 2015
Study Start
April 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
March 3, 2017
Record last verified: 2015-03