The British Heart Foundation Older Patients With Non-ST SEgmeNt elevatIOn myocaRdial Infarction Randomized Interventional TreAtment Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,518
- Locations
- 74
- Primary Endpoint
- Time to cardiovascular death or non-fatal MI (defined by the fourth universal definition) from randomization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 75 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Time to cardiovascular death or non-fatal MI (defined by the fourth universal definition) from randomization
Time Frame: 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 Outcomes
- Bleeding(Up to 1 year)
- 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)
- 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)
- Quality of Life using EQ-5D-5L and quality adjusted life years (QALY)(Up to 5 years)
- Costs to the NHS and personal social services(Up to 5 years)
- 25% increase in serum creatinine concentration(Within 7 days of invasive care)
- Incremental cost per QALY gained at 1 year(Up to 5 years)
- Renal replacement therapy(Within 7 days of invasive care)