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Welcome
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11 February 2012
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| [ Print-friendly version ] |
| Surgical Treatment for Ischaemic Heart Failure Trial (STICH) |
| ISRCTN | ISRCTN09382700 |
| ClinicalTrials.gov identifier | |
| Public title | Surgical Treatment for Ischaemic Heart Failure Trial (STICH) |
| Scientific title | Surgical Treatment for Ischaemic Heart Failure Trial (STICH): a multicentre randomised interventional treatment trial |
| Acronym | N/A |
| Serial number at source | 5148 |
| Study hypothesis |
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. |
| Lay summary | |
| Ethics approval | Hull and East Riding REC approved on the 4th August 2005 (ref: 05/MRE00/51) |
| Study design | Multicentre randomised interventional treatment trial |
| Countries of recruitment | United Kingdom, International |
| Disease/condition/study domain | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 22/12/2005 |
| Anticipated end date | 30/05/2007 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | Planned sample size: 2800 |
| Interventions |
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 |
| Primary outcome measure(s) | CABG combined with MED compared to MED alone, measured up to 6 years. |
| Secondary outcome measure(s) |
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 |
| Sources of funding |
1. National Institute for Health Research (NIHR) (UK)
2. National Institutes of Health (NIH) (USA) - National Heart, Blood and Lung Institute (ref: 5 U01 HL069015-4) |
| Trial website | |
| Publications | |
| Contact name | Mr Mike Lammiman |
| Address |
Department of Cardiology
Castle Road |
| City/town | Cottingham |
| Zip/Postcode | HU16 5JQ |
| Country | United Kingdom |
| mike.lammiman@hey.nhs.uk | |
| Sponsor | Duke University (USA) |
| Address | School of Medicine |
| City/town | Durham |
| Zip/Postcode | NC 27710 |
| Country | United States of America |
| Sponsor website: | http://www.duke.edu/ |
| Date applied | 07/07/2010 |
| Last edited | 13/07/2010 |
| Date ISRCTN assigned | 07/07/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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