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A Trial in Stable Intermediate Coronary Lesions and Grey-zone FFR Values (GzFFR)

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ClinicalTrials.gov Identifier: NCT02425969
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : March 3, 2017
Sponsor:
Collaborators:
British Heart Foundation
University of Glasgow
Information provided by (Responsible Party):
Golden Jubilee National Hospital

Tracking Information
First Submitted Date  ICMJE March 30, 2015
First Posted Date  ICMJE April 24, 2015
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE April 2015
Actual Primary Completion Date October 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2015)		 Angina status as per Seattle Angina Questionnaire [ Time Frame: 3 months ]
Anginal severity as measured by the Seattle Angina Score at 3 months compared with baseline in patients randomized to PCI versus medical therapy.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2015)
  • MACE [ Time Frame: 3 and 12 months ]
    MACE (Death, myocardial infarction, urgent revascularisation and stroke) in patients randomized to PCI versus medical therapy.
  • Myocardial infarction [ Time Frame: 3 and 12 months ]
    Myocardial infarction in patients randomized to PCI versus medical therapy.
  • Urgent Revascularisation [ Time Frame: 3 and 12 months ]
    Urgent Revascularisation of the grey-zone FFR lesion in patients randomized to PCI versus medical therapy.
  • Total number of anti-anginal medications [ Time Frame: 3 and 12 months ]
    Total number of anti-anginal medications in patients randomized to PCI versus medical therapy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial in Stable Intermediate Coronary Lesions and Grey-zone FFR Values
Official Title  ICMJE 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
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.
Detailed Description Pressure derived fractional flow reserve (FFR) is recognised as being the gold standard method of assessing the physiological significance of angiographically intermediate lesions. A grey-zone exists between the originally validated cut-off for ischemia of <0.75 and the conventionally adopted cut- off of ≤0.80. Pilot data from our centre has suggested that only 1 in 3 coronary arteries with grey-zone FFR values demonstrate myocardial perfusion defects on stress cardiac MRI and others have suggested that the clinical outcomes in patients with grey-zone FFR are favorable with medical therapy alone. As such, stenting all lesions with grey-zone FFR (as currently recommended) may represent over-treatment and could attenuate the overall benefit of an FFR strategy. In addition to this there are flow derived resistance indices of stenosis severity that have superior diagnostic accuracy and may be helpful in correctly classifying patients with grey-zone FFR. In this study we will a comprehensive analysis of lesions with grey-zone FFR values (0.75-0.82 inclusive) using invasive hyperemic pressure, flow and resistance derived indices of severity with quantitative and qualitative 3T perfusion MRI to enable identification of the best invasive predictors of true perfusion defects on 3T cardiac MRI. Patients will be randomised to optimal medical therapy alone versus optimal medical therapy with PCI and followed up for the primary endpoint of anginal control as measured by the Seattle Angina Questionnaire at 3 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Grey-zone Fractional Flow Reserve
  • Intermediate Coronary Lesions
  • Stable Angina
  • Coronary Physiology
Intervention  ICMJE
  • Procedure: PCI
    Patients will have balloon angioplasty and coronary stent insertion for their grey-zone FFR lesion.
  • Drug: Optimal Medical Therapy
    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.
Study Arms  ICMJE
  • Experimental: Optimal Medical Therapy
    Patients 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
    Intervention: Drug: Optimal Medical Therapy
  • Active Comparator: PCI with Optimal Medical Therapy
    Patients 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:
    • Procedure: PCI
    • Drug: Optimal Medical Therapy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2017)		 108
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2015)		 120
Actual Study Completion Date  ICMJE October 1, 2016
Actual Primary Completion Date October 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients >18 years
  2. 30-80% Diameter Stenosis on QCA
  3. Stable angina
  4. Non ST-elevation myocardial infarction (NSTEMI) with stable symptoms
  5. Able to provide informed consent

Exclusion Criteria:

  1. STEMI within 5 days
  2. Tortuous vessels which would render pressure wire studies difficult or impossible
  3. Heavily calcified vessels which would render pressure wire studies difficult or impossible
  4. Unstable symptoms requiring definitive interventional management
  5. Severe claustrophobia
  6. Age >90 years
  7. Life expectancy <1 year
  8. Estimated Glomerular Filtration Rate <30 mls/min/1.73m2
  9. Inability to undergo MRI scanning due to metallic implant or incompatible permanent pacemaker
  10. Severe asthma or inability to safely receive an adenosine infusion
  11. Left mainstem disease ≤50% or if considered clinically significant by the operating cardiologist either on angiography or intravascular ultrasound.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02425969
Other Study ID Numbers  ICMJE GzFFR Protocol Version 2.1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Golden Jubilee National Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Golden Jubilee National Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • British Heart Foundation
  • University of Glasgow
Investigators  ICMJE
Principal Investigator: Keith G Oldroyd, M.D. National Health Service
PRS Account Golden Jubilee National Hospital
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP