Condition category
Circulatory System
Date applied
03/10/2007
Date assigned
19/03/2008
Last edited
19/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Miguel Uva

ORCID ID

Contact details

Hospital da Cruz Vermelha
Rua Duarte Galvao 54
Lisbon
1549-008
Portugal
+351 21 7714000
uvamiguel@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PROMISS

Study hypothesis

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

Ethics approval received from the Hospital da Cruz Vemelha Ethics Committee on the 4th April 2005.

Study design

Prospective, randomised, controlled, single blinded, single centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

19/04/2005

Overall trial end date

30/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant 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

Recruitment start date

19/04/2005

Recruitment end date

30/01/2008

Locations

Countries of recruitment

Portugal

Trial participating centre

Hospital da Cruz Vermelha
Lisbon
1549-008
Portugal

Sponsor information

Organisation

Hospital da Cruz Vermelha (Portugal)

Sponsor details

Rua Duarte Galvao
Lisbon
1549-008
Portugal

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Hospital da Cruz Vermelha (Portugal)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Merck Sharp & Dohme Lda. (Portugal)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes