Myocardial IschemiaBaMINCT05149846
Pre-conditioning by Balloon-inflation on Myocardial Injury
A study testing Pre-conditioning in people with Myocardial Ischemia, run by Vastra Gotaland Region.
Trial summary
Study objectives: To test pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart, followed by 10 minutes rest prior to PCI reduces the risk of myocardial injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Pre-conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2024
- 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.
- Indication for complex PCI, defined as:
- PCI of a chronic total occlusion
- Two-stent PCI of a bifurcation lesion.
- PCI of severely calcified lesion
- Preprocedural biomarker Troponin-I within normal range
- Left ventricular ejection fraction >50%
- Written informed consent obtained
Who cannot join
- Previous randomization in the study
- Decompensated heart failure requiring inotropic /adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization
- Recent PCI (<3 months)
- Known previous myocardial infarction in the target vessel or regional wall motion abnormalities within the myocardium subtended by the target vessel(s)
- Any contraindication for Cardiac magnetic resonance imaging
- Pregnancy
About this study
Official title: Effect of Pre-conditioning by Balloon-inflation on Myocardial Injury During Complex Percutaneous Coronary Intervention - a Clinical Trial
Study objectives:
To test pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart, followed by 10 minutes rest prior to PCI reduces the risk of myocardial injury.
Read more
Study design:
Single-center, open-label, randomized controlled trial
Study population:
Patients with indication for complex PCI. Patients will be randomized prior to PCI to pre-conditioning by intracoronary balloon inflation in the target vessel proximal to the target lesion(s) versus no pre-conditioning followed by a 10-minute waiting period prior to PCI. PCI will then be performed as per standard of care. Cardiac biomarkers will be drawn at baseline and 6, 24 and 48 hours after PCI. Cardiac magnetic resonance imaging will be performed at 48 hours and 6 months post PCI.
Read the detailed description
The primary objective of this study is to test pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart followed by 10 minutes rest prior to percutaneous coronary intervention (PCI) reduces the risk of myocardial injury.
Except for the extended duration of balloon inflations, no study-specific therapy will be administered to the patients. All patients will receive treatment according to current guidelines. A follow-up visit will be performed at approximately 6, 24, 48 hours and at 6 months.
The population studied are patients with indication for complex PCI. Patients will be randomized, after providing written informed consent, prior to PCI to pre-conditioning by three consecutive intracoronary balloon inflation in the target vessel proximal to the target lesion(s) versus no pre-conditioning followed by a 10-minute waiting period prior to PCI, PCI will then be performed as per standard of care. Cardiac biomarkers will be drawn at baseline and 6 hours, 24 hours and 48 hours after PCI. Cardiac magnetic resonance imaging will be performed at 48 hours and 6 months post PCI.
Three consecutive balloon occlusions performed for approximate 60 seconds and spaced approximate 120 seconds apart, followed by a 10-minute waiting period prior to PCI.
Cardiac Magnetic Resonance imaging (CMR) will be used to assess size of myocardial infarction at 48±6 hours and 6 months±30 days post PCI. CMR examination includes administration of contrast and one additional blood test (hematocrit, necessary to assess extracellular volume).
Echocardiography can be used before randomization as per standard of care before PCI. Echocardiography will be used to assess wall motion score index, left ventricular ejection fraction at 24 hours and serial examinations can be performed at the discretion of the PI 12-lead Electrocardiogram (ECG) will be used to assess at baseline, during intervention, at 48 hours and serial examinations can be performed at the discretion of the PI.
Apart from the routine laboratory tests, blood samples (troponin-I, troponin-T, creatine kinase MB fraction [CKMB]) will be collected at baseline, 6±1 hour, 24±6 hours 48±6 hours after PCI. After collection blood samples will be analyzed at hospitals clinical laboratory and destructed directly after analyses.
- Conditions
- Myocardial Ischemia
- Being tested
- Pre-conditioning
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-conditioningProcedure or surgery
Pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart followed by 10 minutes rest prior to PCI
| Study group | Role | What they receive |
|---|---|---|
| Pre-conditioning | Other | Pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart followed by 10 minutes rest prior to PCI Receives: Procedure: Pre-conditioning |
| Controll | No intervention | No pre-conditioning, standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac troponin-I
Area-under the curve of cardiac troponin-I
Measured: within 48 hours
Infarct size
Procedural infarct size as assessed by cardiac magnetic resonance imaging
Measured: 48 hours
Infarct size
Procedural infarct size as assessed by cardiac magnetic resonance imaging
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Never started
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.
- More trials run by Vastra Gotaland RegionThe 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
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Björn Redfors, MD, PhD, Principal investigator, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149846
- Sponsor's protocol ID
- BaMI
- Acronym
- BaMI
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-conditioning by Balloon-inflation on Myocardial Injury During Complex Percutaneous Coronary Intervention - a Clinical Trial
- ClinicalTrials.gov ID
- NCT05149846
- Acronym / sponsor ID
- BaMI / BaMI
- Conditions
- Myocardial Ischemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Dec 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.
Study objectives:
To test pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart, followed by 10 minutes rest prior to PCI reduces the risk of myocardial injury.
Study design:
Single-center, open-label, randomized controlled trial
Study population:
Patients with indication for complex PCI. Patients will be randomized prior to PCI to pre-conditioning by intracoronary balloon inflation in the target vessel proximal to the target lesion(s) versus no pre-conditioning followed by a 10-minute waiting period prior to PCI. PCI will then be performed as per standard of care. Cardiac biomarkers will be drawn at baseline and 6, 24 and 48 hours after PCI. Cardiac magnetic resonance imaging will be performed at 48 hours and 6 months post PCI.
Detailed description
The primary objective of this study is to test pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart followed by 10 minutes rest prior to percutaneous coronary intervention (PCI) reduces the risk of myocardial injury.
Except for the extended duration of balloon inflations, no study-specific therapy will be administered to the patients. All patients will receive treatment according to current guidelines. A follow-up visit will be performed at approximately 6, 24, 48 hours and at 6 months.
The population studied are patients with indication for complex PCI. Patients will be randomized, after providing written informed consent, prior to PCI to pre-conditioning by three consecutive intracoronary balloon inflation in the target vessel proximal to the target lesion(s) versus no pre-conditioning followed by a 10-minute waiting period prior to PCI, PCI will then be performed as per standard of care. Cardiac biomarkers will be drawn at baseline and 6 hours, 24 hours and 48 hours after PCI. Cardiac magnetic resonance imaging will be performed at 48 hours and 6 months post PCI.
Three consecutive balloon occlusions performed for approximate 60 seconds and spaced approximate 120 seconds apart, followed by a 10-minute waiting period prior to PCI.
Cardiac Magnetic Resonance imaging (CMR) will be used to assess size of myocardial infarction at 48±6 hours and 6 months±30 days post PCI. CMR examination includes administration of contrast and one additional blood test (hematocrit, necessary to assess extracellular volume).
Echocardiography can be used before randomization as per standard of care before PCI. Echocardiography will be used to assess wall motion score index, left ventricular ejection fraction at 24 hours and serial examinations can be performed at the discretion of the PI 12-lead Electrocardiogram (ECG) will be used to assess at baseline, during intervention, at 48 hours and serial examinations can be performed at the discretion of the PI.
Apart from the routine laboratory tests, blood samples (troponin-I, troponin-T, creatine kinase MB fraction [CKMB]) will be collected at baseline, 6±1 hour, 24±6 hours 48±6 hours after PCI. After collection blood samples will be analyzed at hospitals clinical laboratory and destructed directly after analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pre-conditioning | Other | Procedure: Pre-conditioningPre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart followed by 10 minutes rest prior to PCI |
| Controll | No intervention | –No pre-conditioning, standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years.
- Indication for complex PCI, defined as:
- Preprocedural biomarker Troponin-I within normal range
- Left ventricular ejection fraction >50%
- Written informed consent obtained
Key exclusion criteria (6 listed)
- Previous randomization in the study
- Decompensated heart failure requiring inotropic /adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization
- Recent PCI (<3 months)
- Known previous myocardial infarction in the target vessel or regional wall motion abnormalities within the myocardium subtended by the target vessel(s)
- Any contraindication for Cardiac magnetic resonance imaging
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 |
|---|---|---|
| Pre-conditioningPre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart followed by 10 minutes rest prior to PCI | Procedure or surgery | Pre-conditioning |
Primary outcome
Cardiac troponin-I
Time frame: within 48 hours
Area-under the curve of cardiac troponin-I
Infarct size
Time frame: 48 hours
Procedural infarct size as assessed by cardiac magnetic resonance imaging
Infarct size
Time frame: 6 months
Procedural infarct size as assessed by cardiac magnetic resonance imaging
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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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.
Björn Redfors, MD, PhD principal investigator
Vastra Gotaland Region
Questions about this trial
What is this clinical trial studying?
A study testing Pre-conditioning in people with Myocardial Ischemia, run by Vastra Gotaland Region.
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 8 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: withdrawn, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Cardiac troponin-I (time frame: within 48 hours). The study lists 3 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 17 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.