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

March 2, 2017 updated by: Golden Jubilee National Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Dunbartonshire
      • Glasgow, Dunbartonshire, United Kingdom, G81 4DY
        • Golden Jubilee National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
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.
Procedure: PCI
Patients will have balloon angioplasty and coronary stent insertion for their grey-zone FFR lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 3 and 12 months
MACE (Death, myocardial infarction, urgent revascularisation and stroke) in patients randomized to PCI versus medical therapy.
3 and 12 months
Myocardial infarction
Time Frame: 3 and 12 months
Myocardial infarction in patients randomized to PCI versus medical therapy.
3 and 12 months
Urgent Revascularisation
Time Frame: 3 and 12 months
Urgent Revascularisation of the grey-zone FFR lesion in patients randomized to PCI versus medical therapy.
3 and 12 months
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.
3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Golden Jubilee National Hospital

Collaborators

British Heart Foundation
University of Glasgow

Investigators

  • Principal Investigator: Keith G Oldroyd, M.D., National Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (ESTIMATE)

April 24, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GzFFR Protocol Version 2.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stable Angina

Clinical Trials on Optimal Medical Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe