Heart Revascularisation Trial - UK
| ISRCTN | ISRCTN66339600 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66339600 |
| Protocol serial number | 2995 |
| Sponsor | Hull and East Yorkshire Hospitals NHS Trust (UK) |
| Funders | Medical Research Council (MRC) (UK), Arthritis Research UK |
- Submission date
- 30/07/2010
- Registration date
- 30/07/2010
- Last edited
- 13/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Mike Lammiman
Scientific
Scientific
Department of Cardiology
Castle Road
Cottingham
HU16 5JQ
United Kingdom
| Mike.Lammiman@hey.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised interventional process of care and treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Heart Revascularisation Trial - UK |
| Study acronym | Heart Revascularisation Trial - UK |
| Study objectives | Patients with heart failure, left ventricular systolic dysfunction and definite coronary disease in whom angina is not the predominant symptom will be identified. Cardiac nuclear techniques or stress echocardiography will then be used to identify patients with substantial stress-induced ischaemia or myocardial hibernation/stunning. Patients with either of these problems will be randomised to best medical treatment alone versus best medical therapy and angiography with the intention of, where possible, revascularisation. Revascularisation may be by whichever conventional means the attending cardiologist and cardiac surgeon agree is advisable. Patients will be followed until 90% of patients in the worst performing group have died to determine the effect of the above interventions on all-cause mortality, symptoms, quality of life and recurrent hospitalisation. |
| Ethics approval(s) | MREC, ref: 0/3/35 |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular |
| Intervention | 1. Optimal medication plus angiography with, if appropriate, CABG 2. Optimal medication Follow-up length: 60 months Study entry: single randomisation only |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Survival |
| Key secondary outcome measure(s) |
Determine whether coronary revascularisation reduces all-cause and cause-specific hospitalisation |
| Completion date | 20/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 140 |
| Total final enrolment | 138 |
| Key inclusion criteria | 1. Heart failure (in the investigators opinion) requiring chronic diuretic therapy 2. Coronary disease as the cause of heart failure as evidenced by a history of previous myocardial infarction, previous revascularisation or previous angiography 3. Left ventricular systolic dysfunction (ejection fraction less than 35%) 4. Stress-induced myocardial ischaemia or evidence of myocardial hibernation/stunning affecting five or more left ventricular segments in a 16-segment model 5. Male and female, lower age limit of 18 years |
| Key exclusion criteria | 1. Inability to give written informed consent. No age limits are stipulated but patients will have to be over 18 years to give consent and some patients may be considered too frail to survive surgery and would be excluded. 2. Patients who are not candidates for coronary artery bypass graft (CABG) surgery because of frailty or serious co-morbidity, e.g., severe lung disease, metastatic carcinoma. N.B. Some patients will be candidates for percutaneous transluminal coronary angioplasty (PTCA) but prior to randomisation (i.e. prior to doing an angiogram for study purposes) the investigator should be willing to send the patient to CABG surgery in case that is the preferred mode of revascularisation. 3. Unstable angina, myocardial infarction or stroke within the preceding 2 months 4. Patients being considered for revascularisation for the relief of chest pain (angina) or for valve surgery |
| Date of first enrolment | 07/03/2003 |
| Date of final enrolment | 20/11/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hull and East Yorkshire Hospitals NHS Trust
Cottingham
HU16 5JQ
United Kingdom
HU16 5JQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2011 | 13/06/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/06/2019: Publication reference and total final enrolment number added.
12/09/2016: No publications found, verifying study status with principal investigator.
