Coronary Artery DiseaseNCT02118025
Coronary Bypass Grafting With Minimal Extracorporeal Circulation System Versus Off-pump Coronary Surgery
An observational study of Coronary Artery Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The investigators aimed to evaluate the clinical results and the inflammatory response of the minimal extracorporeal circulation system (MECC) Compared with off-pump coronary revascularization (OPCABG). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Off-pump coronary artery bypass graft and Mini extracorporeal circulation bypass
- Type of treatment
- Surgery or procedure
- How many people
- 230 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2006to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 230 patients with indication for coronary surgery established on the basis of current published guidelines. All patients provided written consent to enter the study.
Who may be able to join
- Indication for coronary surgery established on the basis of current published guidelines
Who cannot join
- Documented preoperative systemic proinflammatory status and/or steroid administration within 6 months before surgery.
- Coexistence of a cardiomyopathy different than coronary artery disease that precise surgical treatment.
- Left ventricle ejection fraction of 40% or less.
- Treatment with erythropoietin (EPO) three months before the intervention
- Hematocrit less than 35% the day prior to the procedure
- Redo surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Comparison of Coronary Bypass Grafting With Minimal Extracorporeal Circulation System (MECC) Versus Off-pump Coronary Surgery. New Insights Into Inflammatory Cytokines.
The investigators aimed to evaluate the clinical results and the inflammatory response of the minimal extracorporeal circulation system (MECC) Compared with off-pump coronary revascularization (OPCABG).
This is a randomized and prospective study in 230 patients with indications for coronary surgery, with 113 patients in the OPCABG group and 117 in the MECC group. The endpoints were the clinical and biochemical results, intra-operative outcomes and the determination of 19 inflammatory circulating markers, 17 of them for the first time analyzed comparing both techniques.
- Conditions
- Coronary Artery Disease
- Being tested
- Off-pump coronary artery bypass graft, Mini extracorporeal circulation bypass
- Keywords
- Off-pump bypass graft surgery, Mini extracorporeal circulation bypass surgery
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-pump coronary artery bypass graftProcedure or surgery
Patients operated with the heart beating, without heart arrest.
Mini extracorporeal circulation bypassProcedure or surgery
Patients operated with a modified extracorporeal circulation system
| Study group | Role | What they receive |
|---|---|---|
| Off-pump coronary artery bypass graft | Patients operated on with off-pump coronary artery bypass graft, beating heart surgery. Receives: Procedure: Off-pump coronary artery bypass graft | |
| Mini extracorporeal circulation bypass | Patients operated on with mini extracorporeal circulation bypass. A modified extracorporeal system. Receives: Procedure: Mini extracorporeal circulation bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes
Number of Participants with Adverse Events, e.g, renal failure, atrial fibrillation, acute myocardial infarct, stroke, redo surgery, death.
Measured: within the first 30 days (plus or minus 3 days) after surgery
Secondary outcomes (7)
Determination of increase over the first 48 hours of plasma levels of 19 circulating markers of inflammatory response.
Determination of increase over the first 48 hours after the operation of plasma levels of 19 circulating markers of inflammatory response. The levels of inflammatory markers are measured in pg / mL and subsequently, the increase over the 48 hours is determined with the area under the curve.
Measured: Area Under the Concentration-Time Curve (AUC 0-48 hours)
Biochemical outcomes
Changes in creatine kinase levels, troponin levels, glucose, leukocytes, platelets, hemoglobin and hematocrit levels. From basal point to 48 hours time after surgery.
Measured: Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Number of distal anastomosis.
Measured: Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Type of grafts used.
Measured: Within the first 30 days (plus or minus 3 days) after surgery
Operative results
time until removal of mechanical respiratory support
Measured: Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Time at intensive care unit (days)
Measured: Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Total hospitalization time (days)
Measured: Within the first 30 days (plus or minus 3 days) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJan 2006
- Primary completionNov 2008
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118025
- Sponsor's protocol ID
- MECC-1
- Other IDs
- MECC-1
- Status last verified
- Mar 2014
- First submitted
- 25 Mar 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Permanyer E, Munoz-Guijosa C, Padro JM, Ginel A, Montiel J, Sanchez-Quesada JL, Vila L, Camacho M. Mini-extracorporeal circulation surgery produces less inflammation than off-pump coronary surgery. Eur J Cardiothorac Surg. 2020 Mar 1;57(3):496-503. doi: 10.1093/ejcts/ezz291.
PubMed 31651944
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Coronary Bypass Grafting With Minimal Extracorporeal Circulation System (MECC) Versus Off-pump Coronary Surgery. New Insights Into Inflammatory Cytokines.
- ClinicalTrials.gov ID
- NCT02118025
- Acronym / sponsor ID
- MECC-1
- Conditions
- Coronary Artery Disease
- Keywords
- Off-pump bypass graft surgery, Mini extracorporeal circulation bypass surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aimed to evaluate the clinical results and the inflammatory response of the minimal extracorporeal circulation system (MECC) Compared with off-pump coronary revascularization (OPCABG).
This is a randomized and prospective study in 230 patients with indications for coronary surgery, with 113 patients in the OPCABG group and 117 in the MECC group. The endpoints were the clinical and biochemical results, intra-operative outcomes and the determination of 19 inflammatory circulating markers, 17 of them for the first time analyzed comparing both techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Off-pump coronary artery bypass graft | – | Procedure: Off-pump coronary artery bypass graftPatients operated on with off-pump coronary artery bypass graft, beating heart surgery. |
| Mini extracorporeal circulation bypass | – | Procedure: Mini extracorporeal circulation bypassPatients operated on with mini extracorporeal circulation bypass. A modified extracorporeal system. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 230 patients with indication for coronary surgery established on the basis of current published guidelines. All patients provided written consent to enter the study.
Key inclusion criteria (1 listed)
- Indication for coronary surgery established on the basis of current published guidelines
Key exclusion criteria (6 listed)
- Documented preoperative systemic proinflammatory status and/or steroid administration within 6 months before surgery.
- Coexistence of a cardiomyopathy different than coronary artery disease that precise surgical treatment.
- Left ventricle ejection fraction of 40% or less.
- Treatment with erythropoietin (EPO) three months before the intervention
- Hematocrit less than 35% the day prior to the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Off-pump coronary artery bypass graftPatients operated with the heart beating, without heart arrest. | Procedure or surgery | Off-pump coronary artery bypass graft |
| Mini extracorporeal circulation bypassPatients operated with a modified extracorporeal circulation system | Procedure or surgery | Mini extracorporeal circulation bypass |
Primary outcome
Clinical outcomes
Time frame: within the first 30 days (plus or minus 3 days) after surgery
Number of Participants with Adverse Events, e.g, renal failure, atrial fibrillation, acute myocardial infarct, stroke, redo surgery, death.
7 secondary outcomes
Determination of increase over the first 48 hours of plasma levels of 19 circulating markers of inflammatory response.
Time frame: Area Under the Concentration-Time Curve (AUC 0-48 hours)
Biochemical outcomes
Time frame: Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Time frame: Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Time frame: Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Time frame: Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Time frame: Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Time frame: Within the first 30 days (plus or minus 3 days) after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Derived from this study: PubMed 31651944Permanyer E, Munoz-Guijosa C, Padro JM, Ginel A, Montiel J, Sanchez-Quesada JL, Vila L, Camacho M. Mini-extracorporeal circulation surgery produces less inflammation than off-pump coronary surgery. Eur J Cardiothorac Surg. 2020 Mar 1;57(3):496-503. doi: 10.1093/ejcts/ezz291.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes (time frame: within the first 30 days (plus or minus 3 days) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02118025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.