Surgical Treatment for Ischaemic Heart Failure Trial (STICH)

ISRCTN	ISRCTN09382700
DOI	https://doi.org/10.1186/ISRCTN09382700
ClinicalTrials.gov number	NCT00023595
Secondary identifying numbers	5148

Submission date: 07/07/2010
Registration date: 07/07/2010
Last edited: 17/07/2014

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

Study website

Contact information

Mr Mike Lammiman
Scientific

Department of Cardiology
Castle Road
Cottingham
HU16 5JQ
United Kingdom

Email	mike.lammiman@hey.nhs.uk

Study information

Study design	Multicentre randomised interventional treatment trial
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 below to request a patient information sheet
Scientific title	Surgical Treatment for Ischaemic Heart Failure Trial (STICH): a multicentre randomised interventional treatment trial
Study objectives	No randomised trial has ever directly compared long-term benefits of surgical and medical treatment of patients with ischaemic heart failure (HF). Along the broad spectrum of severity of ischaemic HF, specific clinical information, such as severe angina or left main coronary artery stenosis, may clearly indicate the need for surgical therapy for some patients. However, a large number of patients fall into a gray zone without clear evidence for benefit from either medical or surgical therapy. For these patients, evidence supporting choice between therapies was never strong and has only been confused by recent studies showing improved outcomes with both therapies. Patients for whom equipoise of anticipated benefit now exists between modern medical and surgical therapy represent the broad population who are appropriate candidates for a randomised trial to provide the context for assessing the value of two therapeutic strategies: 1. Medication (MED) alone 2. MED and coronary artery bypass grafting (CABG) The study is also being run in the USA and includes surgical ventricular reconstruction as a treatment option in those sites only. As of 13/07/2010 the study is seeking a protocol amendment to extend follow-up for another 9 years.
Ethics approval(s)	Hull and East Riding REC, 04/08/2005, ref: 05/MRE00/51
Health condition(s) or problem(s) studied	Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Intervention	1. Optical medication (for heart failure according to National Institute for Clinical Excellence [NICE] guidelines) 2. CABG and optimal medication Total duration of treatment: up to 6 years maximum Follow-up length: 36 months
Intervention type	Other
Primary outcome measure	CABG combined with MED compared to MED alone, measured up to 6 years.
Secondary outcome measures	Measured up to 6 years: 1. Cardiac magnetic resonance (CMR) of left ventricle (LV) shape, size and function for predicting the benefit of a specific treatment strategy 2. Nuclear cardiology and/or echocardiography testing of myocardial ischaemia
Overall study start date	22/12/2005
Completion date	30/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 2800
Key inclusion criteria	1. Men 2. Women who are not of childbearing potential 3. Aged 18 years or above 4. Who have a left ventricular ejection fraction (LVEF) less than 0.35 measured by cardiac magnetic resonance (CMR) ventriculogram, gated single photon emission computed tomography (SPECT) ventriculogram, echocardiography, or contrast ventriculogram within three months of trial entry 5. Who have coronary artery disease suitable for revascularisation
Key exclusion criteria	1. Failure to provide informed consent 2. Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement 3. Cardiogenic shock (within 72 hours of randomization) as defined by the need for intra-aortic balloon support or the requirement for intravenous inotropic support 4. Plan for percutaneous intervention of coronary artery disease 5. Recent acute myocardial infarction judged to be an important cause of left ventricular dysfunction 6. History of more than one prior coronary bypass operation 7. Non-cardiac illness with a life expectancy of less than 3 years 8. Non-cardiac illness imposing substantial operative mortality 9. Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode) 10. Previous heart, kidney, liver, or lung transplantation 11. Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device MED Therapy Eligibility Criteria: 12. Absence of left main coronary artery disease as defined by an intraluminal stenosis of 50% or greater 13. Absence of Canadian Class III angina or greater (angina markedly limiting ordinary activity)
Date of first enrolment	22/12/2005
Date of final enrolment	30/05/2007

Locations

Countries of recruitment

England
United Kingdom
United States of America

Study participating centre

Department of Cardiology

Cottingham
HU16 5JQ
United Kingdom

Sponsor information

Duke University (USA)
University/education

School of Medicine
Durham
NC 27710
United States of America

Website	http://www.duke.edu/
"ROR"	https://ror.org/00py81415

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

National Institutes of Health (NIH) (USA) - National Heart, Blood and Lung Institute (ref: 5 U01 HL069015-4)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/12/2007	Yes	No
Results article	results	23/04/2009	Yes	No
Results article	results	01/05/2009	Yes	No
Results article	results	03/08/2010	Yes	No
Results article	results	03/08/2010	Yes	No
Results article	results	28/04/2011	Yes	No
Results article	results	28/04/2011	Yes	No
Results article	results	01/03/2012	Yes	No
Results article	results	29/05/2012	Yes	No
Results article	results	01/01/2013	Yes	No
Results article	results	01/05/2013	Yes	No
Results article	results	07/05/2013	Yes	No
Results article	results	01/10/2013	Yes	No
Results article	results	01/10/2013	Yes	No
Results article	results	01/11/2013	Yes	No
Results article	results	01/12/2013	Yes	No
Results article	results	01/08/2014	Yes	No