Grey-zone Fractional Flow ReserveGzFFRNCT02425969
A Trial in Stable Intermediate Coronary Lesions and Grey-zone FFR Values
A study testing PCI and Optimal Medical Therapy in people with Grey-zone Fractional Flow Reserve and Intermediate Coronary Lesions, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Grey-zone Fractional Flow Reserve, Intermediate Coronary Lesions, Stable Angina
- What is being tested?
- PCI and Optimal Medical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2015to 1 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years
- 30-80% Diameter Stenosis on QCA
- Stable angina
- Non ST-elevation myocardial infarction (NSTEMI) with stable symptoms
- Able to provide informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Golden Jubilee National Hospital
Glasgow, Dunbartonshire, G81 4DY
About this study
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
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.
Read the 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.
- Conditions
- Grey-zone Fractional Flow Reserve, Intermediate Coronary Lesions, Stable Angina, Coronary Physiology
- Being tested
- PCI, Optimal Medical Therapy
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
Patients will have balloon angioplasty and coronary stent insertion for their grey-zone FFR lesion.
Optimal Medical TherapyDrug
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 group | Role | What they receive |
|---|---|---|
| Optimal Medical Therapy | Experimental | 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 Receives: Drug: Optimal Medical Therapy |
| PCI with Optimal Medical Therapy | Active comparator | 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. Receives: Procedure: PCI; Drug: Optimal Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
MACE
MACE (Death, myocardial infarction, urgent revascularisation and stroke) in patients randomized to PCI versus medical therapy.
Measured: 3 and 12 months
Myocardial infarction
Myocardial infarction in patients randomized to PCI versus medical therapy.
Measured: 3 and 12 months
Urgent Revascularisation
Urgent Revascularisation of the grey-zone FFR lesion in patients randomized to PCI versus medical therapy.
Measured: 3 and 12 months
Total number of anti-anginal medications
Total number of anti-anginal medications in patients randomized to PCI versus medical therapy.
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion1 Oct 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Grey-zone Fractional Flow ReserveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Collaborators
- British Heart Foundation, University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Keith G Oldroyd, M.D., Principal investigator, National Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425969
- Sponsor's protocol ID
- GzFFR Protocol Version 2.1
- Acronym
- GzFFR
- Status last verified
- Mar 2015
- First submitted
- 30 Mar 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 32114516
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02425969
- Acronym / sponsor ID
- GzFFR / GzFFR Protocol Version 2.1
- Conditions
- Grey-zone Fractional Flow Reserve, Intermediate Coronary Lesions, Stable Angina, Coronary Physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Collaborators
- British Heart Foundation, University of Glasgow
- Study start
- Apr 2015
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal Medical Therapy | Experimental | Drug: Optimal Medical TherapyPatients 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 comparator | Procedure: PCI, Drug: Optimal Medical TherapyPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients >18 years
- 30-80% Diameter Stenosis on QCA
- Stable angina
- Non ST-elevation myocardial infarction (NSTEMI) with stable symptoms
- Able to provide informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCIPatients will have balloon angioplasty and coronary stent insertion for their grey-zone FFR lesion. | Procedure or surgery | PCI with Optimal Medical Therapy |
| Optimal Medical TherapyOptimal 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. | Drug | Optimal Medical Therapy, PCI with Optimal Medical Therapy |
Primary outcome
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.
4 secondary outcomes
MACE
Time frame: 3 and 12 months
Myocardial infarction
Time frame: 3 and 12 months
Urgent Revascularisation
Time frame: 3 and 12 months
Total number of anti-anginal medications
Time frame: 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Derived from this study: PubMed 32114516Hennigan 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith G Oldroyd, M.D. principal investigator
National Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI and Optimal Medical Therapy in people with Grey-zone Fractional Flow Reserve and Intermediate Coronary Lesions, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angina status as per Seattle Angina Questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02425969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.