A study to evaluate the benefit of medical therapy versus angiography and stenting in patients with heart attacks - The BHF SENIOR RITA Trial
| ISRCTN | ISRCTN11343602 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11343602 |
| ClinicalTrials.gov number | NCT03052036 |
| Secondary identifying numbers | CPMS 31701 |
- Submission date
- 03/10/2016
- Registration date
- 19/10/2016
- Last edited
- 04/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Coronary artery disease (CAD), also known as ischemic heart disease, is one of the leading causes of death worldwide. CAD develops because of the build-up of fatty deposits (plaque) on the walls of the coronary arteries (the arteries that supply the heart with oxygen-rich blood), leading to a range of problems, including heart attack and angina (chest pain). Over recent years, there have been improvements in medications and technologies to treat CAD but these have been primarily tested in younger patients. Previous studies suggest that older patients (75 years and over) are not well represented in clinical research and these patients, in particular those who are frail and those suffering from other conditions, are less likely to receive advanced medications and medical procedures. This study will look at patients over the age of 75 who have come to the hospital after having a heart attack. The aim of this study is to find out whether undergoing a procedure called an angiography (which shows whether there are any blockages in the heart arteries) as well as the latest medications recommended for heart attacks is a more effective treatment strategy than medication alone in terms of prolonging life.
Who can participate?
Adults over the age of 75 who have been admitted to a participating hospital with a heart attack.
What does the study involve?
Participants are randomly allocated to one of two groups. In the first group, patients will receive the latest medications recommended for heart attacks. In the second group, in addition to these medications, patients will have coronary angiography. This involves having a substance called contrast medium is injected into the body which highlights the blood vessels in the heart as it moves through them. An X-ray machine is then used to view the arteries to see if there are any blockages. If there is a blockage, then participants may undergo surgery to reopen the blocked blood vessels if appropriate. The techniques used in this study are standard techniques and are performed by experienced cardiologists (heart doctors). At the start of the study and then after 6 months and 1 year, participants complete a range of questionnaires to assess their frailty, quality of life and cognitive function (thinking and memory skills). Information about frailty and quality of life is also collected annually for a 5-year period in order to see which of the two groups live better and longer.
What are the possible benefits and risks of participating?
There are no direct benefits to patients other than receiving close follow-ups via clinic visits and telephone interviews that are not routinely offered in the NHS. Participation and the results of the study will help inform the medical community on how best to treat future patients with this condition. There are no notable risks involved with participating in this study.
Where is the study run from?
Freeman Hospital and 24 other NHS hospitals in England, Scotland and Wales (UK)
When is the study starting and how long is it expected to run for?
January 2015 to March 2024
Who is funding the study?
British Heart Foundation (UK)
Who is the main contact?
Prof. Vijay Kunadian, vijay.kunadian@newcastle.ac.uk
Contact information
Scientific
Translational and Clinical Research Institute
Faculty of Medical Sciences
4th Floor William Leech Building
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0)191 208 4591 |
|---|---|
| vijay.kunadian@newcastle.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Treatment, Surgery |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The British Heart Foundation older patients with non-ST SEgmeNt elevatIOn myocaRdial infarction Randomized Interventional TreAtment Trial |
| Study acronym | BHF SENIOR-RITA |
| Study hypothesis | Primary objective: To determine the impact of a routine invasive strategy on one-year cardiovascular death and non-fatal myocardial infarction (MI) compared with a conservative treatment strategy in older patients (≥75 years) with NSTEMI. Secondary objectives: To determine the impact of a routine invasive strategy compared with a conservative strategy on: 1. All-cause death 2. Cardiovascular or non-cardiovascular death 3. Recurrent myocardial infarction 4. Urgent coronary revascularisation 5. Recurrent hospitalisation for myocardial infarction 6. Hospitalization for heart failure 7. Stroke 8. Bleeding (BARC 2) 9. Procedural and in-hospital complications 10. Length of time spent at home 11. Frailty and quality of life |
| Ethics approval(s) | North East - Newcastle & North Tyneside 2 Research Ethics Committee, 03/08/2016, ref: 16/NE/0238 |
| Condition | Non-ST segment elevation myocardial infarction |
| Intervention | Following consent, patients will be randomized to one of two groups. Group 1: Participants undergo a coronary angiography (heart artery X-ray test) and, if appropriate, coronary revascularisation (treatment with balloon or stents or bypass surgery) plus optimal medical therapy. Group 2: Participants receive conservative management (optimal medical therapy alone) The study interventions are standard of care in patients with coronary artery disease and will be performed by interventional cardiologists at local sites with considerable experience in these clinical procedures. Following randomization, all baseline data required for the study including baseline demographics, medical history/co-morbidities (Charlson Index), risk factors, current NSTEMI/admission details, medications history will be collected during hospitalisation. Results of investigations performed as part of routine care of patients including full blood count, serum urea, creatinine concentrations, lipids, glucose and peak troponin concentration will be recorded. Data from baseline ECG will be collected for information on ST-T changes. Additional study related data including MoCA scores (baseline and 1-year), frailty scores, quality of life (EQ-5D-5L), use of health services and patient costs will also be collected. Echocardiographic data will be collected where available. Angiographic and procedural data will be collected from those that undergo invasive care. Detailed angiographic analysis will be carried out in Newcastle. Rockwood and Fried frailty score will be calculated for all patients at baseline, 6 months, 1 year and yearly thereafter for 5 years. Quality of life (QOL) assessments using the EQ-5D-5L will be requested at baseline (pre-randomisation), 30 days, 3 months, 6 months, and at 1 year. Data will be collected during research clinic follow-up visits where feasible (i.e. at baseline, 6 and 12 months). Where this is not feasible, patients will be given the questionnaires to take home at the appropriate trial visits or will be posted out to patients. Patients will be asked to complete the questionnaires and return the completed questionnaires. If questionnaires are not returned after 2 weeks, data will be collected by telephone interviews with the patient or with their carer, where possible. In addition, for the EQ-5D-5L, a proxy-rated version is available for relatives/carers to rate how they expect the patient views their current quality of life. Proxy data (EQ-5D-5L proxy version 2) will be collected at all time points. The relatives/carers will be asked to complete a simple contact form to provide their personal details and to sign this form to agree to Newcastle Clinical Trials Unit having their identifiable information. This will be returned to the trial management team who will send the questionnaires. In addition, costs of treatment in both trial arms will be quantified by collecting data on the use of secondary, primary and personal social services (PSS) at baseline (and at each follow-up period) in a bespoke health and PSS utilisation questionnaire. Patients will be invited to attend research clinics for follow-up visits where feasible. Where this is not feasible, telephone follow-up will be carried out. If required, home visits by the research team will be organised in order to obtain follow-up data from patients. |
| Intervention type | Mixed |
| Primary outcome measure | Time to cardiovascular death or non-fatal MI within one year is determined by analysing the number of deaths one year after randomisation. |
| Secondary outcome measures | 1. All-cause, cardiovascular and non-cardiovascular death rates are measured using hospital records and ONS continuously until study end 2. Recurrent myocardial infarction rates are measured using patient records and HES data during index hospitalisation (Baseline), 6 months, 1 year and annually up to 10 years 3. Hospitalisation for heart failure rate is measured using patient records during index hospitalisation (Baseline), 6 months, 1 year and annually up to 10 years 4. Urgent coronary revascularisation rate is measured using patient records during index hospitalisation (Baseline), 6 months, 1 year and annually up to 10 years 5. Recurrent hospitalisation for myocardial infarction is measured using patient records during index hospitalisation (Baseline), 6 months, 1 year and annually up to 10 years 6. Stroke rate is measured using patient records and HES data during index hospitalisation (Baseline), 6 months, 1 year and annually up to 10 years 7. Bleeding (BARC ≥2) rate is measured using patient records and HES data during index hospitalisation (Baseline), 6 months, 1 year and annually up to 10 years 8. Procedural complication (including death, MI, major bleeding (BARC definition), ≥ 25% increase in serum creatinine concentration from baseline, need for renal replacement therapy, stroke) rate is measured using hospital records during index hospitalisation (baseline) 9. Length of time spent at home is measured using the Time & Travel Questionnaire- telephone or clinic visit at 6 months 10. Frailty is measured using Fried and Rockwood frailty scores at baseline 6 months and 1 year and annually up to 5 years 11. Quality of Life is measured using EQ-5D-5L and quality adjusted life years (QALY) at baseline, 6 months and 1 year and annually up to 5 years 12. Costs to the NHS and personal social services are measured using a questionnaire at clinic or telephone at baseline, 6 months and 1 year and annually up to 5 years 13. Incremental cost per QALY gained at 1 year is measured using a questionnaire at clinic or telephone at 1 year |
| Overall study start date | 10/01/2014 |
| Overall study end date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 75 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1680; UK Sample Size: 1680 |
| Total final enrolment | 1516 |
| Participant inclusion criteria | 1. Aged ≥75 years 2. Type 1 NSTEMI during index hospitalisation |
| Participant exclusion criteria | 1. Patients presenting with STEMI or unstable angina 2. Patients with cardiogenic shock 3. Patients with known life expectancy 4. Patients in whom neither the patient nor the consultee are able and willing to provide written informed consent 5. Previous inclusion in the BHF SENIOR-RITA trial 6. Inability to undergo invasive coronary angiography, such as no vascular access site, or absolute contraindication to coronary revascularisation |
| Recruitment start date | 24/10/2016 |
| Recruitment end date | 31/03/2023 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Newcastle upon Tyne
NE7 7DN
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
Whineys Heys Road
Blackpool
FY8 8NR
United Kingdom
Melrose
TD6 9BS
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Calow
Chesterfield
S44 5BL
United Kingdom
Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom
Darlington
DL3 6HX
United Kingdom
St. Anne’s House
729 The Ridge
St. Leonards-on-sea
TN37 7PT
United Kingdom
Edinburgh
EH16 4SA
United Kingdom
East Kilbride
G75 8RG
United Kingdom
Lincoln County Hospital
Greetwell Road
Lincoln
LN2 5QY
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Stockton-on-Tees
TS19 8PE
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Centre for Biomedical Research
Barnsley Road
Sheffield
S5 7AU
United Kingdom
Manchester
M23 9LT
United Kingdom
South Shields
NE34 0DY
United Kingdom
Swansea
SA6 6NL
United Kingdom
Woodhorn
Ashington
NE63 9JJ
United Kingdom
Paisley
PA2 9PN
United Kingdom
Basildon
SS16 5NL
United Kingdom
Ayr
KA6 6DX
United Kingdom
Gateshead
NE9 6SX
United Kingdom
Sponsor information
Hospital/treatment centre
Freeman Hospital
Freeman Road
High Heaton
Newcastle-Upon-Tyne
NE7 7DN
England
United Kingdom
"ROR" |
https://ror.org/05p40t847 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study will be presented at a major cardiovascular scientific session and published in a high impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Vijay Kunadian (Chief Investigator), Vijay.kunadian@newcastle.ac.uk. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Results article | 01/09/2024 | 04/09/2024 | Yes | No |
Editorial Notes
04/10/2024: Contact details updated.
04/09/2024: Publication reference added.
04/03/2024: The following changes were made to the study record:
1. The target number of participants was changed from 2300 to 1680.
2. Total final enrolment added.
3. The intention to publish date was changed from 30/06/2024 to 30/09/2024.
01/09/2022: The recruitment end date has been changed from 30/09/2022 to 31/03/2023.
01/02/2022: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/09/2029 to 31/03/2024.
2. The intention to publish date was changed from 01/08/2021 to 30/06/2024.
02/09/2021: The recruitment end date was changed from 30/09/2021 to 30/09/2022.
02/12/2020: ClinicalTrials.gov number added.
14/08/2020: Recruitment to this study is no longer paused.
01/05/2020: Due to current public health guidance, recruitment for this study has been paused.
10/03/2020: The public contact was removed.
03/10/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2019 to 30/09/2021.
2. The public contact was changed.
28/03/2019: The condition has been changed from "Specialty: Cardiovascular disease, Primary sub-specialty: Atherothrombosis; UKCRC code/ Disease: Cardiovascular/ Diseases of arteries, arterioles and capillaries" to "Non-ST segment elevation myocardial infarction" following a request from the NIHR.
06/08/2018: The study contacts were updated.
