Condition category
Circulatory System
Date applied
03/10/2016
Date assigned
19/10/2016
Last edited
19/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 that 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 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 in heart attack is 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 in heart attack. 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 six months and one 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 five year period in order to look 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 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 September 2029

Who is funding the study?
British Heart Foundation (UK)

Who is the main contact?
Ms Jaki Begum
jaki.begum@newcastle.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Jaki Begum

ORCID ID

Contact details

Newcastle Clinical Trials Unit
Newcastle University
1-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
+44 191 208 8753
jaki.begum@newcastle.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31701

Study information

Scientific title

The British Heart Foundation older patients with non-ST SEgmeNt elevatIOn myocaRdial infarction Randomized Interventional TreAtment Trial

Acronym

BHF SENIOR-RITA Trial

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

North East - Newcastle & North Tyneside 2 Research Ethics Committee, 03/08/2016, ref: 16/NE/0238

Study design

Randomised; Both; Design type: Treatment, Surgery

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Cardiovascular disease, Primary sub-specialty: Atherothrombosis; UKCRC code/ Disease: Cardiovascular/ Diseases of arteries, arterioles and capillaries

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

Other

Phase

Drug names

Primary outcome measures

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 trial start date

10/01/2014

Overall trial end date

30/09/2029

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged ≥75 years
2. Type 1 NSTEMI during index hospitalisation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 2300; UK Sample Size: 2300

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

30/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Freeman Hospital
Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
Cardiology Polwarth Building Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Trial participating centre

Victoria Hospital
Blackpool Teaching Hospitals NHS Foundation Trust Whineys Heys Road
Blackpool
FY8 8NR
United Kingdom

Trial participating centre

Borders General Hospital
Huntlyburn
Melrose
TD6 9BS
United Kingdom

Trial participating centre

University Hospital Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Chesterfield Royal Hospital
Chesterfield Road Calow
Chesterfield
S44 5BL
United Kingdom

Trial participating centre

Tayside Medical Science Centre
Ninewells Hospital Level 3 George Pirie Way
Dundee
DD1 9SY
United Kingdom

Trial participating centre

Darlington Memorial Hospital
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom

Trial participating centre

Conquest Hosptial
East Sussex Healthcare NHS Trust St. Anne’s House 729 The Ridge
St. Leonards-on-sea
TN37 7PT

Trial participating centre

Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

Hairmyres Hospital
Eaglesham Road
East Kilbride
G75 8RG
United Kingdom

Trial participating centre

Lincolnshire Heart Centre
United Lincolnshire Healthcare Trust Lincoln County Hospital Greetwell Road
Lincoln
LN2 5QY
United Kingdom

Trial participating centre

The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

University Hospital of North Tees
Hardwick Road
Stockton-on-Tees
TS19 8PE
United Kingdom

Trial participating centre

Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom

Trial participating centre

Northern General Hospital
Cardiovascular Research Unit Centre for Biomedical Research Barnsley Road
Sheffield
S5 7AU
United Kingdom

Trial participating centre

Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Trial participating centre

South Tyneside District Hospital
Harton Lane
South Shields
NE34 0DY
United Kingdom

Trial participating centre

Morriston Hospital
Abertawe Bro Morgannwg University Health Board
Swansea
SA6 6NL
United Kingdom

Trial participating centre

Wansbeck General Hospital
Northumbria Healthcare NHS Foundation Trust Woodhorn
Ashington
NE63 9JJ
United Kingdom

Trial participating centre

Royal Alexandra Hospital
Corsebar Road
Paisley
PA2 9PN
United Kingdom

Trial participating centre

Basildon University Hospital
Nethermayne
Basildon
SS16 5NL
United Kingdom

Trial participating centre

University Hospital Ayr
Dalmellington Road
Ayr
KA6 6DX
United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Queen Elizabeth Avenue
Gateshead
NE9 6SX
United Kingdom

Sponsor information

Organisation

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Sponsor details

Freeman Hospital
Freeman Road
High Heaton
Newcastle-Upon-Tyne
NE7 7DN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The Study will be presented at a major cardiovascular scientific session and published in a high impact peer reviewed journal between March and August 2021.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from. Please contact Dr Vijay Kunadian (Chief Investigator), Vijay.kunadian@newcastle.ac.uk

Intention to publish date

01/08/2021

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes