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| [ ...Back to search results ] | [ Print-friendly version ] |
| Off-pump vs on-pump surgery in patients with stable coronary artery disease |
| ISRCTN | ISRCTN59539154 |
| ClinicalTrials.gov identifier | |
| Public title | Off-pump vs on-pump surgery in patients with stable coronary artery disease |
| Scientific title | A randomised comparative study of patients undergoing myocardial revascularisation with or without cardiopulmonary bypass surgery |
| Acronym | MASS III |
| Serial number at source | 1926/01/114 |
| Study hypothesis | The aim of the MASS III Trial is to compare medical effectiveness, safety, cerebral injury, quality of life, cost-effectiveness of coronary surgery with (on-pump) or without (off-pump) cardiopulmonary bypass. |
| Lay summary | |
| Ethics approval | Institutional Review Board (Comissão de Ética para Análise de Projetos de Pesquisa - CAPPesq) approved on 19/10/2001. |
| Study design | Randomised controlled comparative trial |
| Countries of recruitment | Brazil |
| Disease/condition/study domain | Coronary artery disease |
| Participants - inclusion criteria |
1. Male or female, age 18 years or older
2. Patients with stable angina pectoris and/or documented ischemia due to multivessel disease and preserved ventricular function 3. Angiographically confirmed multivessel coronary artery disease (CAD) with >=70% lesions in at least two major epicardial vessels and at least two separate coronary artery territories (LAD, LCX and RCA) 4. Patients who are eligible for coronary surgery both with and without cardiopulmonary bypass circuit 5. Willing to comply with all follow-up study visits 6. Signed and received a copy of the informed consent Note: Non-significant left main stenoses can be included |
| Participants - exclusion criteria |
1. Age under 18 years
2. Severe congestive hearth failure, New York Heart Association (NYHA) Class III or IV, or pulmonary edema 3. Prior valve replacement or coronary artery bypass graft (CABG) surgery 4. Prior percutaneous coronary intervention (PCI) with stent implantation within 6 months 5. Prior stroke within 6 months or patients with stroke that occurred more than 6 months ago with significant residual neurological involvement, as reflected in a Rankin score >= 1 6. Need for concomitant major surgery e.g. valve replacement, resection ventricular aneurysm, congenital heart disease vascular surgery of the carotid artery, or thoracic-abdominal aorta 7. Concomitant medical disorders making clinical follow-up at least 5 years unlikely or impossible e.g. neoplastic, hepatic, or other severe disease 8. Q-wave myocardial infarction in the previous 6 weeks 9. Hemorrhagic diathesis or hypercoagulability 10. Thoracic deformations technically precluding surgery without extracorporeal circulation 11. Unable to give informed consent |
| Anticipated start date | 31/01/2002 |
| Anticipated end date | 31/01/2010 |
| 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 | 311 |
| Interventions |
Trial operators were required to perform optimum coronary revascularisation in accordance with the current best practices. The surgery was performed by physicians experienced in both on-pump and off-pump bypass surgery techniques. Surgical access to the heart was through a standard median sternotomy in all cases. All incisions and closure techniques were the same for both groups, limiting variability and maintaining blinding of group assignment for patients, family and cardiologists. A cell saver reservoir (COBE Cardiovascular, Inc., USA) was spun down and returned to all patients when the quantity was sufficient.
Off-pump strategies: Off-pump surgery used the Octopus stabiliser described in detail elsewhere. In brief, the distal ends of the two suction arms of the stabiliser are placed on the beating heart on both sides of the target coronary artery. The proximal parts are fixed to the operating table. Through the application of negative pressure, the target area of the heart is sufficiently immobilised to allow the safe construction of the anastomosis of the graft with the recipient artery. On-pump technique: Conventional coronary artery surgery with cardiopulmonary bypass was accomplished with every effort to minimize the impact of cardiopulmonary bypass. Patients without diabetes received 1 gram of hydrocortisone sodium succinate (SoluCortef®, Pharmacia & Upjohn Co., USA) intravenously before of anesthesia. This procedure will be made only in the on-pump technique. |
| Primary outcome measure(s) |
The following will be assessed at discharge and 5-year follow-up:
1. Incidence of cardiovascular mortality 2. Cerebrovascular accident 3. Non-fatal myocardial infarction 4. Refractory angina requiring revascularisation |
| Secondary outcome measure(s) |
The following were assessed at discharge and at 5-year follow-up:
1. Non-cardiac mortality 2. Presence and severity of angina 3. Quality of life, using the 36-item Short Form health survey (SF-36) 4. Cost-effectiveness |
| Sources of funding | Zerbini Foundation (Fundaciao Zerbini) (Brazil) |
| Trial website | |
| Publications | |
| Contact name | Prof Whady Hueb |
| Address |
Av. Dr. Eneas Carvalho Aguiar 44 AB
Sala 114 |
| City/town | Sao Paulo |
| Zip/Postcode | 05403000 |
| Country | Brazil |
| Sponsor | Zerbini Foundation (Fundação Zerbini) (Brazil) |
| Address |
Av. Dr. Eneas Carvalho Aguiar 44 AB
Sala 114 |
| City/town | Sao Paulo |
| Zip/Postcode | 05403-000 |
| Country | Brazil |
| Sponsor website: | http://www.incor.usp.br |
| Date applied | 21/02/2008 |
| Last edited | 11/09/2008 |
| Date ISRCTN assigned | 10/03/2008 |
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| © 2012 ISRCTN unless otherwise stated. | |
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