Prospective Randomised comparison of Off-pump and on-pump MultIvessel coronary artery bypasS Surgery: analysis of early graft patency by multi-slice computed tomography
| ISRCTN | ISRCTN58800729 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58800729 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/10/2007
- Registration date
- 19/03/2008
- Last edited
- 31/12/2020
- 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
Dr Miguel Uva
Scientific
Scientific
Hospital da Cruz Vermelha
Rua Duarte Galvao 54
Lisbon
1549-008
Portugal
| Phone | +351 21 7714000 |
|---|---|
| uvamiguel@hotmail.com |
Study information
| Study design | Prospective, randomised, controlled, single blinded, single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Prospective Randomised comparison of Off-pump and on-pump MultIvessel coronary artery bypasS Surgery (PROMISS): analysis of early graft patency by multi-slice computed tomography |
| Study acronym | PROMISS |
| Study objectives | Coronary artery bypass grafting performed without cardiopulmonary bypass (off-pump coronary artery bypass [OPCAB]) has the same early graft patency as if performed with cardiopulmonary bypass (on-pump coronary artery bypass [ONCAB]) and may have reduced complication rate. |
| Ethics approval(s) | Ethics approval received from the Hospital da Cruz Vemelha Ethics Committee on the 4th April 2005. |
| Health condition(s) or problem(s) studied | Multivessel coronary artery disease |
| Intervention | Patients undergo coronary artery bypass grafting with internal mammary artery, radial or saphenous vein in the two groups using the same anaesthetic protocol, the same graft anastomotic techniques and the same peri-operative (the only exception is heparin dose) and post operative medical treatment. Coronary artery bypass grafting is performed without cardio-pulmonary bypass (off-pump group) or with the use of cardio-pulmonary bypass (on-pump group). Duration of treatment: two surgical methods are compared in PROMISS so the duration of treatment is that of the surgical procedures (3 - 5 hours). Patients are followed at 1 month (clinical exam) and 6 months (clinical exam, quality of life and stress test). |
| Intervention type | Other |
| Primary outcome measure | Graft patency at 4 - 6 weeks evaluated by 16 slice computed tomography. |
| Secondary outcome measures | 1. Post-operative adverse events 2. Neurocognitive testing at baseline and 4 - 6 weeks 3. Quality of life at baseline and 6 months 4. Adverse events and stress test at 6 months |
| Overall study start date | 19/04/2005 |
| Completion date | 30/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 150 |
| Key inclusion criteria | 1. Patients between 30 and 90 years 2. Multivessel disease 3. Indication for primary coronary artery bypass graft (CABG) for at least three distal anastomoses according to consensus given by two independent surgeons |
| Key exclusion criteria | 1. Patient requiring emergency surgery such as: 1.1. Ventilatory support 1.2. Intravenous inotropic therapy 1.3. Cardiogenic shock 1.4. Catheterism accident 1.5. Q-wave myocardial infarction in evolution 2. Need for associated procedures 3. Renal insufficiency or serum creatinine 1.5 times superior to the upper limit normal values 4. Atrial fibrillation 5. Known allergy to contrast material 6. Dyspnoea at rest or inability to hold breath 7. Women with child bearing potential (for the purpose of this study women which have menopause for less than 12 months will be excluded, with exception for those with surgical menopause) 8. Inability to give inform consent |
| Date of first enrolment | 19/04/2005 |
| Date of final enrolment | 30/01/2008 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Hospital da Cruz Vermelha
Lisbon
1549-008
Portugal
1549-008
Portugal
Sponsor information
Hospital da Cruz Vermelha (Portugal)
Hospital/treatment centre
Hospital/treatment centre
Rua Duarte Galvao
Lisbon
1549-008
Portugal
"ROR" |
https://ror.org/0120ae790 |
|---|
Funders
Funder type
Industry
Hospital da Cruz Vermelha (Portugal)
No information available
Merck Sharp & Dohme Lda. (Portugal)
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 | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/07/2008 | 31/12/2020 | Yes | No |
| Results article | results | 01/10/2010 | 31/12/2020 | Yes | No |
Editorial Notes
31/12/2020: The following changes have been made:
1. Publication references added.
2. The final enrolment number has been added from the reference.
