Conservative Non-Invasive Versus Routine Invasive Management in Coronary Artery Bypass Surgery Patients with Non ST Elevation Elevation Acute Coronary Syndrome

NCT01895751 | Completed Phase 4 DMC

• 1 other identifier: GN-11-CA456
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

Background: Most coronary artery bypass grafts (CABG) are diseased or blocked within 10 years of surgery meaning CABG survivors have an ever increasing risk of recurrent angina, heart attack and death. Given the large number of CABG survivors in the United Kingdom (UK), and the complexities of their clinical management, their heart health problems and related treatment are an increasing challenge in the UK National Health Service (NHS) and worldwide. There is considerable controversy in the NHS and internationally about how to best manage patients with prior CABG and unstable angina / non-ST elevation acute coronary syndromes (NSTE-ACS). This is because there is no robust evidence to inform treatment practices or clinical guidelines since, historically, these patients have been excluded from randomised trials. This is the rationale for our study. Aims: Our overall aim is to undertake a clinical trial of conservative non-invasive management with optimal drug therapy versus routine invasive management in NSTE-ACS patients with prior CABG during routine clinical care in NHS hospitals across the UK. Our trial is a proof-of-concept study of feasibility, safety, potential efficacy and health economics. Hypothesis: A routine invasive approach in NSTE-ACS patients with prior CABG will not be superior to a conservative non-invasive approach with optimal medical therapy. Design: The pilot study will involve 60 patients recruited in large urban hospitals (Western Infirmary, Glasgow Royal Infirmary) and district general hospitals (Royal Alexandra Hospital, Royal Blackburn Hospital (RBH)) to reflect usual practice in the UK. One of these hospitals (RBH) has an on-site cardiac catheterization laboratory, whereas the other hospitals refer patients who have been triaged for invasive management to the regional cardiothoracic centre (the Golden Jubilee National Hospital). In this proof of concept study, the investigators aim to gather information about screening, recruitment, randomisation, patient characteristics (including comorbidity and quality of life) and initial clinical outcomes to inform the design of the definitive trial. The follow-up will be in line with standard clinical care i.e. 30-42 days and 1 year. The investigators will hold data in the longer term to enable long-term follow-up analyses. The investigators will record information on NSTE-ACS patients with prior CABG who are ineligible to take part or who do not wish to be randomised as part of all follow-up registry of 'all-comers'.

Conditions

Non ST Elevation Myocardial Infarction; Unstable Angina

Keywords

Non-ST elevation myocardial infarction (NSTEMI); Non-ST elevation acute coronary syndrome (NSTE-ACS); Unstable Angina; Medical therapy; Coronary angiogram; Percutaneous coronary intervention; Coronary artery bypass surgery; Coronary revascularization; Health economics

Outcome Measures

Primary Outcomes (1)

• The post-randomization rate of major adverse events (co-primary composite outcome), one composite outcome for EFFICACY and one composite outcome for SAFETY.

  Each composite outcome (EFFICACY, SAFETY) includes major adverse events. The comparison between the incidence of each outcome according to treatment group will assess the between group difference in the proportion of major adverse events in patients allocated to non-invasive (conservative) management compared to invasive management. PRIMARY EFFICACY ENDPOINTS are defined as all-cause mortality, rehospitalization for refractory ischemia/angina, myocardial infarction or heart failure. The endpoints will be assessed during the study until the final randomized patient has completed 1 year follow-up. The events will be adjudicated by an independent Clinical Event Committee. PRIMARY SAFETY ENDPOINTS are defined as Bleeding (Bleeding Academic Research Consortium (BARC) types 2-4), stroke, procedure-related MI (Type 4a, Universal Definition), worsening renal function defined as a 25% reduction in glomerular filtration rate (GFR) or hemodialysis during the index hospitalization.

  Post randomisation, expected average followup of 1 year

Secondary Outcomes (4)

• Quality of life

  Baseline through longer term follow-up (average follow-up 12 months

• Health economics

  Baseline through long term followup - average of 12 months

• Angina severity assessment with Canadian Cardiovascular Society angina class

  Baseline through long term followup - 12 months average

• Hospitalization for refractory ischemia and/or angina

  Follow-up post-randomization

Study Arms (2)

Conservative therapy

NO INTERVENTION

Conservative therapy group involves optimal medical therapy according to local hospital protocols with selective invasive management as clinically appropriate. Patients assigned to the conservative group may be referred for invasive management if the patient meets one of the following pre-specified criteria: Recurrent or refractory (class III or IV) angina with documented ischaemic ECG changes while on "optimal" medical therapy. New ST segment elevation in two contiguous leads without Q waves or T wave inversion greater than 3 mm or development of hemodynamic instability Deterioration in heart failure status (defined as Killip class 3 or 4).

Invasive management

ACTIVE COMPARATOR

Invasive management is timed as appropriate according to local NHS protocols. Usually, invasive management is expected to be performed in line with contemporary guidelines.

Procedure: Invasive management

Interventions

Invasive management PROCEDURE

Invasive management includes coronary and graft angiography (diagnostic imaging test) and coronary and/or graft revascularization with percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG), as clinically appropriate.

Invasive management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unstable angina or non-ST elevation myocardial infarction
• Stabilised symptoms without recurrent chest pain or IV therapy for 12 hrs when ambulant.

You may not qualify if:

• Refractory ischaemia (i.e. recurrent angina with minimal exertion or at rest (i.e. Canadian Cardiovascular Society class III or IV) not controlled by medical therapy)
• Cardiogenic shock
• Inability to give informed consent
• Unsuitable for invasive management.

Sponsors & Collaborators

• NHS National Waiting Times Centre Board: lead
• University of Glasgow: collaborator

Study Sites (5)

Royal Blackburn Hospital

Blackburn, East Lancashire, BB2 3HH, United Kingdom

Location

Royal Alexandra Hospital, Corsebar Road, Paislay

Glasgow, Scotland, PA2 9PN, United Kingdom

Location

Western Infirmary, Dumbarton Road

Glasgow, G11 6NT, United Kingdom

Location

Glasgow Royal Infirmary, 84 Castle St

Glasgow, G4 0SF, United Kingdom

Location

Golden Jubilee National Hospital, Clydebank, Dunbartonshire

Glasgow, G81 4DY, United Kingdom

Location

Related Publications (18)

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Related Links

• Scottish Cardiac Society - Research

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Colin Berry, MD PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Colin Berry

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: July 10, 2013
• Study Start: April 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

GB (5)