The British Heart Foundation SENIOR-RITA Trial
- Conditions
- NSTEMI - Non-ST Segment Elevation MI
- Registration Number
- NCT03052036
- Lead Sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1518
- Aged ≥ 75 years
- Type 1 NSTEMI during index hospitalisation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to cardiovascular death or non-fatal MI (defined by the fourth universal definition) from randomization Up to 5 years To determine the impact of a routine invasive strategy on cardiovascular death and non-fatal myocardial infarction (MI) compared with a conservative treatment strategy in older patients (≥75 years) with NSTEMI.
- Secondary Outcome Measures
Name Time Method Recurrent myocardial infarction Up to 5 years Hospitalisation for heart failure Up to 5 years Urgent coronary revascularisation Up to 5 years Recurrent hospitalisation for myocardial infarction Up to 5 years Stroke Up to 5 years Length of time spent at home Up to 5 years Bleeding Up to 1 year Bleeding according to BARC Criteria
All cause, cardiovascular and non-cardiovascular death rates Up to 5 years Fried and Rockwood frailty scores Up to 5 years Procedural complications Within 7 days of invasive care Perforation, myocardial infarction (Type 4a), coronary dissection, TIA, Death in Cath Lab, Aortic dissection
Quality of Life using EQ-5D-5L and quality adjusted life years (QALY) Up to 5 years Quality of life will be measured using the EQ-5D-5L instrument\[REF: The EuroQol Group (1990). EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 16(3):199-208html \] (paper and telephone versions), with the results for each participant converted into quality-adjusted life-years (QALYs) using the area under the curve approach, a standard methodology for this process,\[REF: Drummond MOB, B; Stoddart, G; Torrance, G. . Methods for the economic evaluation of Health Care Programmes: Oxford University Press 2005.\] with the responses to the EQ-5D-5L scored using the appropriate value set for the United Kingdom, which is expected to be available by the time of the analysis. REF: Office for Health Economics. New OHE Publications: An EQ-5D-5L Value Set for England. Available at: https://www.ohe.org/news/new-ohe-publications-eq-5d-5l-value-set-england. Accessed February 03 2017\]
Costs to the NHS and personal social services Up to 5 years 25% increase in serum creatinine concentration Within 7 days of invasive care 25% increase in serum creatinine concentration from baseline (hospitalisation)
Incremental cost per QALY gained at 1 year Up to 5 years Renal replacement therapy Within 7 days of invasive care Need for renal replacement therapy
Trial Locations
- Locations (40)
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
Scroll for more (30 remaining)Pinderfields General Hospital🇬🇧Wakefield, West Yorkshire, United Kingdom