Heart DiseaseNCT01482780
Evaluation of a Local Preconditioning Effect in Patients Undergoing Cardiac Surgery
A study testing PICSO in people with Heart Disease and Coronary Artery Bypass Graft Triple Vessel, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of the study is to analyze the potential of pressure controlled intermittent coronary sinus occlusion (PICSO) to prevent/reverse the ischemic burden as well as reperfusion injury. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Disease, Coronary Artery Bypass Graft Triple Vessel
- What is being tested?
- PICSO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2012to Mar 2014
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of either sex and between 18 and 85 years of age scheduled for surgery without severe confounding disease will be asked to participate in the study.
- Written informed consent will be obtained in eligible patients.
Who cannot join
- Patients with unstable angina pectoris and/or myocardial infarction within the last 30 days, as well as persons with planned concomitant valvular interventions will be excluded. Patients with malignoma, severe hepatic, renal and pulmonary disease will also be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EASY-TRIAL: Evaluation of a Local Preconditioning Effect in Patients Undergoing Cardiac Surgery
The aim of the study is to analyze the potential of pressure controlled intermittent coronary sinus occlusion (PICSO) to prevent/reverse the ischemic burden as well as reperfusion injury. To achieve insight into the clinical significance of this local preconditioning effect, global hemodynamics, cardiac performance and clinical outcome in the first 30 days will be related to the ability of this intervention to protect the myocardium in elective surgical procedures, ameliorating cellular decay and preserving the microcirculation therefore improving graft flow, reducing enzyme leakage and finally improving myocardial performance.
Read the detailed description
- Patients undergoing elective coronary artery bypass graft (CABG) will be enrolled in this study.
- A computerized randomization process is used to obtain similar distributions within each group. Stratification will be done by the severity of coronary artery disease, age and sex.
- Routine blood sampling will be performed the day before surgery as well as a transthoracic echocardiography (TTE) study to determine ventricular volumes and valvular function.
- A modified Minnesota quality of Life questionnaire will be assessed and these data will be compared with 30 days outcome data screened in an outpatient environment.
- A 12 lead electrocardiogram will be obtained. To assess eligibility and to assure grouping (stratification \& randomization) patients will be scored using the additive EuroSCORE. Pre-, intra-, and postoperative (up to 72 hrs) measurements of myocardial enzyme leakage will be performed using standard diagnostic procedures (cardiac troponin T, CK-MB, and total creatine kinase), as well as serial electrocardiograms and echocardiograms.
- Perioperative infarction will be assessed as the development of new persistent regional wall motion abnormalities in echocardiography together with electrocardiographic alterations and CK-MB increases and new Q-wave PMI.
- Sequential cytokine analyses (IL-1, IL-6, IL-8, IL-10, IL-17, VEGF and TNF- alpha ) preoperatively, at the beginning of the operation, the beginning of ECC and 6,24 h and 30 days postop.
- Serial quantification of global and regional wall motion will be recorded using TEE measurements during surgery.
- Being tested
- PICSO
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICSODevice
Also called PICSO, Miracor medical Systems, Austria
PICSO (pressure controlled intermittent coronary sinus occlusion) will be used in the pre ECC period. The procedure of PICSO will be performed in analogy to retrograde cardioplegia.
| Study group | Role | What they receive |
|---|---|---|
| PICSO | Experimental | PICSO (pressure controlled intermittent coronary sinus occlusion), a special coronary sinus catheter will be introduced after induction of anaesthesia until going on bypass. Receives: Device: PICSO |
| Control | No intervention | normal procedure of preparing Bypass grafts. Equivalent time before going on Bypass is determined as control period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in enzyme leakage measured by AUC.
Enzyme leakage (Troponin T, CK-MB) will be measured preoperatively, at the beginning of the operation, the beginning of ECC at the time of reperfusion the arrival on the ICU and 6,12,24,48 and 72 hours postop and the area under the curve will be calculated (AUC until 72 hours).
Study Hypotheses:
- PICSO reduces troponin T leakage about 30 % measured by AUC until 72h in comparison to controls.
- PICSO improves 30d and long-term outcome
Measured: 72 hours postop
Secondary outcomes (3)
Combined endpoint of major adverse cardiovascular events (MACE) and mortality after 30 days.
Measured: 30 days
N-terminales pro brain natriuretic peptide (NT-pro BNP) values at 1 day pre-surgery as well as 30d and 6 months post-operative
Measured: 30 days
Pre-operative (1d) as well as post-operative (6, 12, 24, 48, 72 h, 30d) C-reactive protein (CRP) measurements
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startMar 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Logistic reasons, lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Werner Mohl, Medical University of Vienna
- Investigators
- Werner Mohl, DDr, Principal investigator, Medical University of Vienna, Abteilung für Herz-, ThoraxchirurgieWerner Mohl, DDr., Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482780
- Sponsor's protocol ID
- EASY-TRIAL
- Status last verified
- Apr 2015
- First submitted
- 29 Nov 2011
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EASY-TRIAL: Evaluation of a Local Preconditioning Effect in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01482780
- Acronym / sponsor ID
- EASY-TRIAL
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistic reasons, lack of funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Dec 2011 (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 aim of the study is to analyze the potential of pressure controlled intermittent coronary sinus occlusion (PICSO) to prevent/reverse the ischemic burden as well as reperfusion injury. To achieve insight into the clinical significance of this local preconditioning effect, global hemodynamics, cardiac performance and clinical outcome in the first 30 days will be related to the ability of this intervention to protect the myocardium in elective surgical procedures, ameliorating cellular decay and preserving the microcirculation therefore improving graft flow, reducing enzyme leakage and finally improving myocardial performance.
Detailed description
- Patients undergoing elective coronary artery bypass graft (CABG) will be enrolled in this study.
- A computerized randomization process is used to obtain similar distributions within each group. Stratification will be done by the severity of coronary artery disease, age and sex.
- Routine blood sampling will be performed the day before surgery as well as a transthoracic echocardiography (TTE) study to determine ventricular volumes and valvular function.
- A modified Minnesota quality of Life questionnaire will be assessed and these data will be compared with 30 days outcome data screened in an outpatient environment.
- A 12 lead electrocardiogram will be obtained. To assess eligibility and to assure grouping (stratification \& randomization) patients will be scored using the additive EuroSCORE. Pre-, intra-, and postoperative (up to 72 hrs) measurements of myocardial enzyme leakage will be performed using standard diagnostic procedures (cardiac troponin T, CK-MB, and total creatine kinase), as well as serial electrocardiograms and echocardiograms.
- Perioperative infarction will be assessed as the development of new persistent regional wall motion abnormalities in echocardiography together with electrocardiographic alterations and CK-MB increases and new Q-wave PMI.
- Sequential cytokine analyses (IL-1, IL-6, IL-8, IL-10, IL-17, VEGF and TNF- alpha ) preoperatively, at the beginning of the operation, the beginning of ECC and 6,24 h and 30 days postop.
- Serial quantification of global and regional wall motion will be recorded using TEE measurements during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICSO | Experimental | Device: PICSOPICSO (pressure controlled intermittent coronary sinus occlusion), a special coronary sinus catheter will be introduced after induction of anaesthesia until going on bypass. |
| Control | No intervention | –normal procedure of preparing Bypass grafts. Equivalent time before going on Bypass is determined as control period |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients of either sex and between 18 and 85 years of age scheduled for surgery without severe confounding disease will be asked to participate in the study.
- Written informed consent will be obtained in eligible patients.
Key exclusion criteria (1 listed)
- Patients with unstable angina pectoris and/or myocardial infarction within the last 30 days, as well as persons with planned concomitant valvular interventions will be excluded. Patients with malignoma, severe hepatic, renal and pulmonary disease will also be excluded
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 |
|---|---|---|
| PICSOAlso: PICSO, Miracor medical Systems, AustriaPICSO (pressure controlled intermittent coronary sinus occlusion) will be used in the pre ECC period. The procedure of PICSO will be performed in analogy to retrograde cardioplegia. | Device | PICSO |
Primary outcome
Reduction in enzyme leakage measured by AUC.
Time frame: 72 hours postop
Enzyme leakage (Troponin T, CK-MB) will be measured preoperatively, at the beginning of the operation, the beginning of ECC at the time of reperfusion the arrival on the ICU and 6,12,24,48 and 72 hours postop and the area under the curve will be calculated (AUC until 72 hours). Study Hypotheses: 1. PICSO reduces troponin T leakage about 30 % measured by AUC until 72h in comparison to controls. 2. PICSO improves 30d and long-term outcome
3 secondary outcomes
Combined endpoint of major adverse cardiovascular events (MACE) and mortality after 30 days.
Time frame: 30 days
N-terminales pro brain natriuretic peptide (NT-pro BNP) values at 1 day pre-surgery as well as 30d and 6 months post-operative
Time frame: 30 days
Pre-operative (1d) as well as post-operative (6, 12, 24, 48, 72 h, 30d) C-reactive protein (CRP) measurements
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Logistic reasons, lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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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.
Werner Mohl, DDr principal investigator
Medical University of Vienna, Abteilung für Herz-, Thoraxchirurgie
Werner Mohl, DDr. study director
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICSO in people with Heart Disease and Coronary Artery Bypass Graft Triple Vessel, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 7 Apr 2015. 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 Austria. 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 was stopped early (reason given: Logistic reasons, lack of funding). Results are not available in the source record.
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?
Reduction in enzyme leakage measured by AUC. (time frame: 72 hours postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2015.