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

Stable Angina Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425969
• Other study ID #: GzFFR Protocol Version 2.1
• Status: Completed
• Phase: N/A
• First received: March 30, 2015
• Last updated: March 2, 2017
• Start date: April 2015
• Est. completion date: October 1, 2016

Study information

• Verified date: March 2015
• Source: Golden Jubilee National Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 primary endpoint of anginal control as measured by the Seattle Angina Questionnaire at 3 months.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Physiology
• Grey-zone Fractional Flow Reserve
• Intermediate Coronary Lesions
• Stable Angina

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Golden Jubilee National Hospital	Glasgow	Dunbartonshire

Sponsors (3)

Lead Sponsor	Collaborator
Golden Jubilee National Hospital	British Heart Foundation, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

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