NSTEMI - Non-ST Segment Elevation MI
Conditions
Keywords
Acute Coronary Syndrome
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.
Interventions
PROCEDURECoronary Angiography
Coronary angiography to determine location of blocked or narrowed arteries.
PROCEDURECoronary revascularisation
PCI or CABG will be performed following coronary angiography at the discretion of the treating cardiologist.
OTHEROptimal 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.
Sponsors
British Heart Foundation
Newcastle University
Newcastle-upon-Tyne Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Fried and Rockwood frailty scores | Up to 5 years | — |
| All cause, cardiovascular and non-cardiovascular death rates | Up to 5 years | — |
| Costs to the NHS and personal social services | Up to 5 years | — |
| Incremental cost per QALY gained at 1 year | 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 |
| Bleeding | Up to 1 year | Bleeding according to BARC Criteria |
| Renal replacement therapy | Within 7 days of invasive care | Need for renal replacement therapy |
| 25% increase in serum creatinine concentration | Within 7 days of invasive care | 25% increase in serum creatinine concentration from baseline (hospitalisation) |
| 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\] |
Countries
United Kingdom
Outcome results
None listed