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

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Golden Jubilee National Hospital
• Collaborators: British Heart Foundation; University of Glasgow

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.