Myocardial IschemiaVENTMICSNCT05109715
The Effect of Mechanical Ventilation on the Occurrence of Myocardial Ischemia: a Pilot Study
A study testing Continued ventilation and Discontinued ventilation in people with Myocardial Ischemia and Hypoxia, run by Jessa Hospital at 1 site in Belgium.
Trial summary
The goal of the proposed pilot study is to determine which method can detect myocardial ischemia at the predefined timepoints during endo-CABG. Additionally, the investigators want to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Hypoxia
- What is being tested?
- Continued ventilation and Discontinued ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Jan 2022to 4 Oct 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Patients undergoing their first elective endo-CABG procedure
- Patients capable of signing the informed consent
- Patients able to speak Dutch or French
Who cannot join
- Ongoing participation in another trial
- Ejection fraction < 50%
- Lung diseases (COPD, asthma)
- Use of corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mechanical Ventilation on the Occurrence of Myocardial Ischemia in Patients Undergoing Endoscopic Coronary Artery Bypass Grafting (Endo-CABG): a Pilot Study
The goal of the proposed pilot study is to determine which method can detect myocardial ischemia at the predefined timepoints during endo-CABG. Additionally, the investigators want to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.
Read the detailed description
CABG is the most effective therapy for patients suffering from coronary artery disease, a condition which annually affects 126 million people worldwide. During this surgery, cardiopulmonary bypass (CPB) takes over the function of the heart and lungs. As a result of the emergence of minimally invasive cardiac surgery (MICS) (e.g. endoscopic-CABG), peripheral CPB with femoral arterial cannulation became the most commonly utilized strategy. However, the use of retrograde arterial perfusion is not without risk. It may result in the upper body and coronary arteries being perfused with deoxygenated blood. The hypoxemia will induce myocardial ischemia and this can harm the cardiac myocytes. A solution for this inconvenience is still lacking. Literature reports that establishing adequate ventilation support should help overcome this phenomenon. However, this approach has not yet been investigated in a clinical trial. In general, this phenomenon is not well recognized in the typical surgical setting, and limited research has been done.
The goal of the proposed pilot study is to determine which method can detect myocardial ischemia at the predefined timepoints during endo-CABG. Additionally, the investigators want to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.
- Conditions
- Myocardial Ischemia, Hypoxia
- Being tested
- Continued ventilation, Discontinued ventilation
- Keywords
- Cardiac surgery, Ventilation
- Medical subject headings
- Myocardial Ischemia, Hypoxia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continued ventilationProcedure or surgery
Ventilation is continued from going on CPB until clamping of the ascending aorta with tidal volume 3ml/kg ideal body weight, Fraction of inspired oxygen (FiO2) 50%, respiratory rate 5/min and Inspiratory:Expiratory (I/E) ratio 1/2.
Discontinued ventilationProcedure or surgery
Ventilation is discontinued after going on CPB and lungs are exposed to atmospheric pressure
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Ventilation is discontinued after going on CPB and lungs are exposed to atmospheric pressure.
Blood will be drawn:
* At baseline: before general anaesthesia
* After start of heart-lung machine
* After clamping the aorta
* Before unclamping the aorta
* After the operation
* 5 h after clamping the aorta
* 12 hours after clamping the aorta
* 24 hours after aortic clamping
* 48h after clamping the aorta
* 72 hours after clamping the aorta Receives: Procedure: Discontinued ventilation |
| Ventilation group | Experimental | Ventilation is continued from going on CPB until clamping of the ascending aorta.
Blood will be drawn:
* At baseline: before general anaesthesia
* After start of heart-lung machine
* After clamping the aorta
* Before unclamping the aorta
* After the operation
* 5 h after clamping the aorta
* 12 hours after clamping the aorta
* 24 hours after aortic clamping
* 48h after clamping the aorta
* 72 hours after clamping the aorta Receives: Procedure: Continued ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection of myocardial ischemia using Cardiac Troponin T (cTn-T)
If the value of Cardiac Troponin T (cTn-T) exceeds 14 ng/L, then cTn-T is able to detect myocardial ischemia at the predefined time points.
Measured: Until 72 hours after clamping the aorta
The detection of myocardial ischemia using Heart-type Fatty Acid Binding Protein (hFABP)
If the value of Heart-type Fatty Acid Binding Protein (hFABP) exceeds 6 ng/L, then hFABP is able to detect myocardial ischemia at the predefined time points.
Measured: Until 5 hours after clamping the aorta
The detection of myocardial ischemia using Creatine Kinase Myocardial Band (CK-MB)
If the value of Creatine Kinase Myocardial Band (CK-MB) exceeds 6.2 µg/L, then CK-MB is able to detect myocardial ischemia at the predefined time points.
Measured: Until 48 hours after clamping the aorta
The detection of myocardial ischemia using Reactive Oxygen Species (ROS)
Reactive Oxygen Species (ROS) measurements include a malondialdehyde assay to assess the lipid peroxidation, an Oxystat test to analyse the total peroxide levels and a protein carbonyl assay to assess the protein damage due to cardiomyocyte dysfunction. Additionally a biopsy will be taken to analyze pro- and anti-oxidants. If a significant increase in lipid peroxidation, total peroxide levels, protein damage and/or pro- and anti-oxidants in the ventilation group compared to the control group is present, then ROS is able to detect myocardial ischemia at the predefined time points.
Measured: Until unclamping the aorta (on average until 64 minutes after clamping the aorta)
The occurence of hypoxemia using blood gas measurement
If the partial pressure of oxygen (PaO2) is lower than 60 mmHg, then hypoxemia is present.
Measured: Until the end of surgery (on average until 203 minutes after the start of the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start24 Jan 2022
- Primary completion18 Apr 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdullah Kaya, PhD, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109715
- Sponsor's protocol ID
- f/2021/118
- Acronym
- VENTMICS
- Status last verified
- Oct 2022
- First submitted
- 27 Oct 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mechanical Ventilation on the Occurrence of Myocardial Ischemia in Patients Undergoing Endoscopic Coronary Artery Bypass Grafting (Endo-CABG): a Pilot Study
- ClinicalTrials.gov ID
- NCT05109715
- Acronym / sponsor ID
- VENTMICS / f/2021/118
- Conditions
- Myocardial Ischemia, Hypoxia
- Keywords
- Cardiac surgery, Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 5 Nov 2021 (actual)
- 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 goal of the proposed pilot study is to determine which method can detect myocardial ischemia at the predefined timepoints during endo-CABG. Additionally, the investigators want to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.
Detailed description
CABG is the most effective therapy for patients suffering from coronary artery disease, a condition which annually affects 126 million people worldwide. During this surgery, cardiopulmonary bypass (CPB) takes over the function of the heart and lungs. As a result of the emergence of minimally invasive cardiac surgery (MICS) (e.g. endoscopic-CABG), peripheral CPB with femoral arterial cannulation became the most commonly utilized strategy. However, the use of retrograde arterial perfusion is not without risk. It may result in the upper body and coronary arteries being perfused with deoxygenated blood. The hypoxemia will induce myocardial ischemia and this can harm the cardiac myocytes. A solution for this inconvenience is still lacking. Literature reports that establishing adequate ventilation support should help overcome this phenomenon. However, this approach has not yet been investigated in a clinical trial. In general, this phenomenon is not well recognized in the typical surgical setting, and limited research has been done.
The goal of the proposed pilot study is to determine which method can detect myocardial ischemia at the predefined timepoints during endo-CABG. Additionally, the investigators want to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Discontinued ventilationVentilation is discontinued after going on CPB and lungs are exposed to atmospheric pressure. Blood will be drawn: * At baseline: before general anaesthesia * After start of heart-lung machine * After clamping the aorta * Before unclamping the aorta * After the operation * 5 h after clamping the aorta * 12 hours after clamping the aorta * 24 hours after aortic clamping * 48h after clamping the aorta * 72 hours after clamping the aorta |
| Ventilation group | Experimental | Procedure: Continued ventilationVentilation is continued from going on CPB until clamping of the ascending aorta. Blood will be drawn: * At baseline: before general anaesthesia * After start of heart-lung machine * After clamping the aorta * Before unclamping the aorta * After the operation * 5 h after clamping the aorta * 12 hours after clamping the aorta * 24 hours after aortic clamping * 48h after clamping the aorta * 72 hours after clamping the aorta |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Patients undergoing their first elective endo-CABG procedure
- Patients capable of signing the informed consent
- Patients able to speak Dutch or French
Key exclusion criteria (4 listed)
- Ongoing participation in another trial
- Ejection fraction < 50%
- Lung diseases (COPD, asthma)
- Use of corticosteroids
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 |
|---|---|---|
| Continued ventilationVentilation is continued from going on CPB until clamping of the ascending aorta with tidal volume 3ml/kg ideal body weight, Fraction of inspired oxygen (FiO2) 50%, respiratory rate 5/min and Inspiratory:Expiratory (I/E) ratio 1/2. | Procedure or surgery | Ventilation group |
| Discontinued ventilationVentilation is discontinued after going on CPB and lungs are exposed to atmospheric pressure | Procedure or surgery | Control group |
Primary outcome
The detection of myocardial ischemia using Cardiac Troponin T (cTn-T)
Time frame: Until 72 hours after clamping the aorta
If the value of Cardiac Troponin T (cTn-T) exceeds 14 ng/L, then cTn-T is able to detect myocardial ischemia at the predefined time points.
The detection of myocardial ischemia using Heart-type Fatty Acid Binding Protein (hFABP)
Time frame: Until 5 hours after clamping the aorta
If the value of Heart-type Fatty Acid Binding Protein (hFABP) exceeds 6 ng/L, then hFABP is able to detect myocardial ischemia at the predefined time points.
The detection of myocardial ischemia using Creatine Kinase Myocardial Band (CK-MB)
Time frame: Until 48 hours after clamping the aorta
If the value of Creatine Kinase Myocardial Band (CK-MB) exceeds 6.2 µg/L, then CK-MB is able to detect myocardial ischemia at the predefined time points.
The detection of myocardial ischemia using Reactive Oxygen Species (ROS)
Time frame: Until unclamping the aorta (on average until 64 minutes after clamping the aorta)
Reactive Oxygen Species (ROS) measurements include a malondialdehyde assay to assess the lipid peroxidation, an Oxystat test to analyse the total peroxide levels and a protein carbonyl assay to assess the protein damage due to cardiomyocyte dysfunction. Additionally a biopsy will be taken to analyze pro- and anti-oxidants. If a significant increase in lipid peroxidation, total peroxide levels, protein damage and/or pro- and anti-oxidants in the ventilation group compared to the control group is present, then ROS is able to detect myocardial ischemia at the predefined time points.
The occurence of hypoxemia using blood gas measurement
Time frame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
If the partial pressure of oxygen (PaO2) is lower than 60 mmHg, then hypoxemia is present.
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 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Abdullah Kaya, PhD principal investigator
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continued ventilation and Discontinued ventilation in people with Myocardial Ischemia and Hypoxia, run by Jessa Hospital at 1 site in Belgium.
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 4 inclusion and 4 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 Oct 2022. 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 Belgium. 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?
The detection of myocardial ischemia using Cardiac Troponin T (cTn-T) (time frame: Until 72 hours after clamping the aorta). The study lists 5 primary outcomes in all. 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 21 Oct 2022.