ClinicalTrials.gov

History of Changes for Study: NCT02425969
A Trial in Stable Intermediate Coronary Lesions and Grey-zone FFR Values (GzFFR)
Latest version (submitted March 2, 2017) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 23, 2015 None (earliest Version on record)
2 June 10, 2015 Recruitment Status, Contacts/Locations and Study Status
3 March 2, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT02425969
Submitted Date:  April 23, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: GzFFR Protocol Version 2.1
Brief Title: A Trial in Stable Intermediate Coronary Lesions and Grey-zone FFR Values (GzFFR)
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2015
Overall Status: Not yet recruiting
Study Start: April 2015
Primary Completion: July 2016 [Anticipated]
Study Completion: July 2017 [Anticipated]
First Submitted: March 30, 2015
First Submitted that
Met QC Criteria:
April 23, 2015
First Posted: April 24, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 23, 2015
Last Update Posted: April 24, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Golden Jubilee National Hospital
Responsible Party: Sponsor
Collaborators: British Heart Foundation
University of Glasgow
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Grey-zone Fractional Flow Reserve
Intermediate Coronary Lesions
Stable Angina
Coronary Physiology
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 120 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
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.
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.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. MACE
[ Time Frame: 3 and 12 months ]

MACE (Death, myocardial infarction, urgent revascularisation and stroke) in patients randomized to PCI versus medical therapy.
2. Myocardial infarction
[ Time Frame: 3 and 12 months ]

Myocardial infarction in patients randomized to PCI versus medical therapy.
3. Urgent Revascularisation
[ Time Frame: 3 and 12 months ]

Urgent Revascularisation of the grey-zone FFR lesion in patients randomized to PCI versus medical therapy.
4. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 90 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Barry W Hennigan, MBBChBAO
Telephone: 0141 951 5000 Ext. 5331
Email: barryhennigan@nhs.net
Central Contact Backup: Keith G Oldroyd, M.D.
Telephone: 0141 951 5000
Email: keith.oldroyd@nhs.net
Study Officials: Keith G Oldroyd, M.D.
Principal Investigator
National Health Service
Locations: United Kingdom, Dunbartonshire
Golden Jubilee National Hospital
Glasgow, Dunbartonshire, United Kingdom, G81 4DY
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services