The British Heart Foundation SENIOR-RITA Trial

NCT ID: NCT03052036

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1518 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2029-06-30

Brief Summary

SENIOR-RITA is a multicentre prospective open-label trial randomizing patients presenting with type 1 NSTEMI aged ≥75 years between invasive and conservative treatment strategies, to compare time from randomisation to cardiovascular death or non-fatal MI

Detailed Description

The population is getting older and heart artery disease is the biggest killer in the UK. Over recent years, there have been improvements in medications and technologies to treat it, but these have been primarily tested in younger patients. Previous research studies suggest that older patients (75 years and over) are not well represented in clinical research and these patients in particular those that are frail and those with co-morbidities are less likely to receive advanced medications and medical procedures. The current study will enrol patients 75 years and over, presenting with a heart attack. If patients agree to participate, they will be randomly allocated to one of two treatment groups. In the first group, patients will receive the latest medications recommended in heart attack. In the second group, in addition to these medications, patients will have coronary angiography. This will show whether they have any blockages in heart arteries. If appropriate, coronary revascularisation by percutaneous coronary intervention (PCI) commonly known as coronary angioplasty or coronary artery bypass grafting, sometimes called CABG (a surgical procedure in which a blood vessel from the leg, arm or chest is used to bypass a narrowed section of a coronary artery) will be carried out. During the trial, frailty scores, cognition measures, co-morbidity indices, questionnaires on quality of life, NHS and personal social services utilization will be collected from the participant and in addition proxy quality of life information will be collected from the participant's carers. Investigators will evaluate which one of the two treatment groups will do better and live longer. Investigators will also collect information on their quality of life and frailty measures for a 5 year period. The trial hopes to recruit 2300 patients from approximately 30 centres across the UK.

Conditions

NSTEMI - Non-ST Segment Elevation MI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Invasive Treatment

Coronary angiography with a view to coronary revascularisation

Group Type: OTHER

Coronary Angiography

Intervention Type: PROCEDURE

Coronary angiography to determine location of blocked or narrowed arteries.

Coronary revascularisation

Intervention Type: PROCEDURE

PCI or CABG will be performed following coronary angiography at the discretion of the treating cardiologist.

Optimal Medical Therapy

Intervention Type: OTHER

Patients to receive conservative treatment in the form of guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE Inhibitors and beta blockers.

Optimal Medical Therapy

Patients to be treated with guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE inhibitors, betabloackers

Group Type: OTHER

Optimal Medical Therapy

Intervention Type: OTHER

Patients to receive conservative treatment in the form of guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE Inhibitors and beta blockers.

Interventions

Coronary Angiography

Coronary angiography to determine location of blocked or narrowed arteries.

Intervention Type: PROCEDURE

Coronary revascularisation

PCI or CABG will be performed following coronary angiography at the discretion of the treating cardiologist.

Intervention Type: PROCEDURE

Optimal Medical Therapy

Patients to receive conservative treatment in the form of guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE Inhibitors and beta blockers.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged ≥ 75 years
• Type 1 NSTEMI during index hospitalisation

Exclusion Criteria

• Patients presenting with STEMI or unstable angina
• Patients with cardiogenic shock
• Patients with known life expectancy <1 year
• Patients in whom neither the patient nor the consultee are able and willing to provide written informed consent
• Previous inclusion in the BHF SENIOR-RITA trial
• Inability to undergo invasive coronary angiography, such as no vascular access site, or absolute contraindication to coronary revascularisation

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British Heart Foundation

OTHER

Sponsor Role: collaborator

Newcastle University

OTHER

Sponsor Role: collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Vijay Kunadian, MBBS MD FRCP

Role: PRINCIPAL_INVESTIGATOR

Newcastle University

Locations

Pinderfields General Hospital

Wakefield, West Yorkshire, United Kingdom

Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

Basildon & Thurrock University Hospitals NHS Foundation Trust

Basildon, , United Kingdom

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, , United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, , United Kingdom

Broomfield Hospital, Mid Essex Hospitals NHS Trust

Broomfield, , United Kingdom

Cumberland Infirmary, North Cumbria University Hospitals NHS Trust

Carlisle, , United Kingdom

St Helier Hospital, Epsom & St Helier University Hospitals NHS Trust

Carshalton, , United Kingdom

Chesterfield Royal Hospital NHS Foundation Trust

Chesterfield, , United Kingdom

County Durham & Darlington NHS Foundation Trust

Darlington, , United Kingdom

Royal Derby Hospital, Derby Teaching Hospitals NHS Foundation Trust

Derby, , United Kingdom

Ninewells Hospital, NHS Tayside

Dundee, , United Kingdom

Lanarkshire East Kilbride NHS Foundation Trust

East Kilbride, , United Kingdom

East Sussex NHS Healthcare Trust

Eastbourne, , United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Gateshead Hospitals NHS Foundation Trust

Gateshead, , United Kingdom

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Royal Alexandra Hospital

Glasgow, , United Kingdom

North Tees and Hartlepool Foundation Trust

Hartlepool, , United Kingdom

NHS Ayrshire & Arran

Kilmarnock, , United Kingdom

Leeds General Infirmary

Leeds, , United Kingdom

United Lincolnshire Healthcare Trust

Lincoln, , United Kingdom

London Royal Free, Royal Free London NHS Foundation Trust

London, , United Kingdom

Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, , United Kingdom

Chelsea and Westminster

London, , United Kingdom

Wythenshawe Hospital, University Hospital of South Manchester NHS Foundation Trust

Manchester, , United Kingdom

Borders General Hospital

Melrose, , United Kingdom

South Tees NHS Foundation Trust

Middlesbrough, , United Kingdom

The Newcastle Upon Tyne Hospital NHS Foundation Trust

Newcastle upon Tyne, , United Kingdom

Northumbria Healthcare NHS Foundation Trust

North Shields, , United Kingdom

Pennine Acute Hospitals NHS Trust

Oldham, , United Kingdom

Plymouth Hospital, Plymouth Hospitals NHS Trust

Plymouth, , United Kingdom

Royal Berkshire Hospital, Royal Berkshire Foundation NHS Trust

Reading, , United Kingdom

East Surrey Hospital, Surrey & Sussex NHS Trust

Redhill, , United Kingdom

Salford Royal NHS Foundation Trust

Salford, , United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , United Kingdom

South Tyneside NHS Foundation Trust

South Shields, , United Kingdom

City Hospitals Sunderland NHS Foundation Trust

Sunderland, , United Kingdom

Torbay Hospital, Torbay & South Devon NHS Foundation Trust

Torquay, , United Kingdom

The York Hospital, York Teaching Hospital NHS Foundation Trust

York, , United Kingdom

Countries

United Kingdom

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Related Links

http://www.who.int/healthinfo/survey/ageingdefnolder/en/

Organisation WH.

Other Identifiers

7910

Identifier Type: -

Identifier Source: org_study_id