Stable Angina Clinical Trial
— GzFFROfficial 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
Verified date | March 2015 |
Source | Golden Jubilee National Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 108 |
Est. completion date | October 1, 2016 |
Est. primary completion date | October 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Golden Jubilee National Hospital | Glasgow | Dunbartonshire |
Lead Sponsor | Collaborator |
---|---|
Golden Jubilee National Hospital | British Heart Foundation, University of Glasgow |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | MACE | MACE (Death, myocardial infarction, urgent revascularisation and stroke) in patients randomized to PCI versus medical therapy. | 3 and 12 months | |
Secondary | Myocardial infarction | Myocardial infarction in patients randomized to PCI versus medical therapy. | 3 and 12 months | |
Secondary | Urgent Revascularisation | Urgent Revascularisation of the grey-zone FFR lesion in patients randomized to PCI versus medical therapy. | 3 and 12 months | |
Secondary | Total number of anti-anginal medications | Total number of anti-anginal medications in patients randomized to PCI versus medical therapy. | 3 and 12 months |
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