An interventional study of Coronary Angiography and Coronary revascularisation in NSTEMI - Non-ST Segment Elevation MI, sponsored by Newcastle-upon-Tyne Hospitals NHS Trust. Active, not recruiting at 40 sites in United Kingdom. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.
Sponsored by Newcastle-upon-Tyne Hospitals NHS Trust · Not applicable, Interventional, and Treatment
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
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.
284 studies on the registry are indexed under Non-ST Elevated Myocardial Infarction; 52 are open to participants now.
This study's enrollment of 1,518 is above the median of 244 across 146 interventional studies indexed under Non-ST Elevated Myocardial Infarction.
Browse Non-ST Elevated Myocardial Infarction studies →Newcastle-upon-Tyne Hospitals NHS Trust is the lead sponsor of 67 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Coronary angiography with a view to coronary revascularisation
Procedure: Coronary Angiography · Procedure: Coronary revascularisation · Other: Optimal Medical Therapy
Patients to be treated with guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE inhibitors, betabloackers
Other: Optimal Medical Therapy
Coronary angiography to determine location of blocked or narrowed arteries.
PCI or CABG will be performed following coronary angiography at the discretion of the treating cardiologist.
Patients to receive conservative treatment in the form of guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE Inhibitors and beta blockers.
Time to cardiovascular death or non-fatal MI (defined by the fourth universal definition) from randomization
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.
Time frame: Up to 5 years
All cause, cardiovascular and non-cardiovascular death rates
Time frame: Up to 5 years
Recurrent myocardial infarction
Time frame: Up to 5 years
Hospitalisation for heart failure
Time frame: Up to 5 years
Urgent coronary revascularisation
Time frame: Up to 5 years
Recurrent hospitalisation for myocardial infarction
Time frame: Up to 5 years
Stroke
Time frame: Up to 5 years
Length of time spent at home
Time frame: Up to 5 years
Fried and Rockwood frailty scores
Time frame: Up to 5 years
Quality of Life using EQ-5D-5L and quality adjusted life years (QALY)
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\]
Time frame: Up to 5 years
Costs to the NHS and personal social services
Time frame: Up to 5 years
Incremental cost per QALY gained at 1 year
Time frame: Up to 5 years
Procedural complications
Perforation, myocardial infarction (Type 4a), coronary dissection, TIA, Death in Cath Lab, Aortic dissection
Time frame: Within 7 days of invasive care
Bleeding
Bleeding according to BARC Criteria
Time frame: Up to 1 year
Renal replacement therapy
Need for renal replacement therapy
Time frame: Within 7 days of invasive care
25% increase in serum creatinine concentration
25% increase in serum creatinine concentration from baseline (hospitalisation)
Time frame: Within 7 days of invasive care
Plan to share: Undecided
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Non-ST Elevated Myocardial Infarction →
Newcastle-upon-Tyne Hospitals NHS Trust