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The British Heart Foundation SENIOR-RITA Trial (SENIOR-RITA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03052036
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : March 23, 2022
Sponsor:
Collaborators:
British Heart Foundation
Newcastle University
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
NSTEMI - Non-ST Segment Elevation MI Procedure: Coronary Angiography Procedure: Coronary revascularisation Other: Optimal Medical Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1668 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The British Heart Foundation Older Patients With Non-ST SEgmeNt elevatIOn myocaRdial Infarction Randomized Interventional TreAtment Trial
Actual Study Start Date : November 2016
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2024

Arm Intervention/treatment
Invasive Treatment
Coronary angiography with a view to coronary revascularisation
Procedure: Coronary Angiography
Coronary angiography to determine location of blocked or narrowed arteries.

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

Other: 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.

Optimal Medical Therapy
Patients to be treated with guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE inhibitors, betabloackers
Other: 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.




Primary Outcome Measures :
  1. Time to cardiovascular death or non-fatal MI (defined by the third 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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052036


Contacts
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Contact: Dr Vijay Kunadian, MBBS MD FRCP 0191 208 5797 vijay.kunadian@newcastle.ac.uk

Locations
Show Show 42 study locations
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
British Heart Foundation
Newcastle University
Investigators
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Principal Investigator: Dr Vijay Kunadian, MBBS MD FRCP Newcastle University
Additional Information:
Publications of Results:
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24.
Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7. Erratum in: Stroke. 2019 Aug;50(8):e239.

Other Publications:
Orimo H, Ito H, Suzuki T, Araki A, Hosoi T, Sawabe M. Reviewing the definition of "elderly". Geriatrics & Gerontology International. 2006;6:149-158
Townsend N, Wickramasinghe K, Bhatnagar P, Smolina K, Nichols M, Leal J, Luengo-Fernandez R, Rayner M. Coronary heart disease statistics 2012 edition. 2012
Machin D, Campbell MJ, Tan SB, Tan SH. Comparing survival curves. Sample size tables for clinical studies. Wiley-Blackwell; 2009:84-101.
Beecham J KM. Costing psychiatric interventions. In: Thornicroft, graham, ed. Measuring mental health needs (second edition). Royal college of psychiatrists, london, 2001, 200-224. Measuring Mental Health Needs 2001;Second Edition 24

Layout table for additonal information
Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03052036    
Other Study ID Numbers: 7910
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: March 23, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Acute Coronary Syndrome