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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

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.

Condition or disease Intervention/treatment Phase
Grey-zone Fractional Flow Reserve Intermediate Coronary Lesions Stable Angina Coronary Physiology Procedure: PCI Drug: Optimal Medical Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2015
Actual Primary Completion Date : October 1, 2016
Actual Study Completion Date : October 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
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.




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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425969


Locations
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United Kingdom
Golden Jubilee National Hospital
Glasgow, Dunbartonshire, United Kingdom, G81 4DY
Sponsors and Collaborators
Golden Jubilee National Hospital
British Heart Foundation
University of Glasgow
Investigators
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Principal Investigator: Keith G Oldroyd, M.D. National Health Service
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Golden Jubilee National Hospital
ClinicalTrials.gov Identifier: NCT02425969    
Other Study ID Numbers: GzFFR Protocol Version 2.1
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2015
Additional relevant MeSH terms:
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Angina, Stable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations