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NCT Number: NCT03052036

The British Heart Foundation SENIOR-RITA Trial

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

NSTEMI - Non-ST Segment Elevation MI Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pinderfields General Hospital, Wakefield, West Yorkshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary Angiography

Procedure

Coronary angiography to determine location of blocked or narrowed arteries.

Coronary revascularisation

Procedure

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

Optimal medical therapy

Other

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

Primary outcomes

  1. 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

  1. All cause, cardiovascular and non-cardiovascular death rates

    Time frame: Up to 5 years

  2. Recurrent myocardial infarction

    Time frame: Up to 5 years

  3. Hospitalisation for heart failure

    Time frame: Up to 5 years

  4. Urgent coronary revascularisation

    Time frame: Up to 5 years

  5. Recurrent hospitalisation for myocardial infarction

    Time frame: Up to 5 years

  6. Stroke

    Time frame: Up to 5 years

  7. Length of time spent at home

    Time frame: Up to 5 years

  8. Fried and Rockwood frailty scores

    Time frame: Up to 5 years

  9. Quality of Life using EQ-5D-5L and quality adjusted life years (QALY)

    Time frame: 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]

  10. Costs to the NHS and personal social services

    Time frame: Up to 5 years

  11. Incremental cost per QALY gained at 1 year

    Time frame: Up to 5 years

  12. Procedural complications

    Time frame: Within 7 days of invasive care

    Perforation, myocardial infarction (Type 4a), coronary dissection, TIA, Death in Cath Lab, Aortic dissection

  13. Bleeding

    Time frame: Up to 1 year

    Bleeding according to BARC Criteria

  14. Renal replacement therapy

    Time frame: Within 7 days of invasive care

    Need for renal replacement therapy

  15. 25% increase in serum creatinine concentration

    Time frame: Within 7 days of invasive care

    25% increase in serum creatinine concentration from baseline (hospitalisation)

Sponsors and collaborators

Lead sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Other

Collaborators

  • British Heart Foundation
  • Newcastle University

Registry information

Official study title

The British Heart Foundation Older Patients With Non-ST SEgmeNt elevatIOn myocaRdial Infarction Randomized Interventional TreAtment Trial

Acronym: SENIOR-RITA

Important dates

Study start
2016
Primary completion
2024
Study completion
2029
First posted
Feb 14, 2017
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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