Myocardial InfarctionPhase 4NCT00334373
Post Conditioning in PCI for Acute ST Elevation Myocardial Infarction
A Phase 4 study testing Post conditioning in people with Myocardial Infarction, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this trial is to compare post-conditioning to standard angioplasty (50/50 chance) in patients who present with an acute heart attack and are taken directly for an angioplasty procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Post conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2006to Oct 2011
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and over
- ST elevation of >/= 2mm in 3 consecutive anterior leads or >/= to 2 mm in leads II, III and AVF with total 8 mm ST shift (ST depression of 1 mm in ant or lat leads)
Who cannot join
- Cardiogenic shock or severe heart failure
- Inability to undergo CMR (metallic objects or claustrophobia)
- Previous MI
- TIMI 2-3 flow in target artery
- Collaterals to infarct related artery > Rentrop grade 1
- Inability to undertake successful PCI at time of angio
- Significant LM disease or requiring CABG during hospital stay
- Inability to proceed with post conditioning within 1 minute of establishing blood flow in culprit artery
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this trial is to compare post-conditioning to standard angioplasty (50/50 chance) in patients who present with an acute heart attack and are taken directly for an angioplasty procedure. Post conditioning is a procedure that involves balloon inflation followed by deflation in a series of cycles that appears to show (based on early data) that it can decrease the amount of damage to the heart muscle as compared to standard angioplasty procedures.
Hypothesis: For Subjects undergoing direct PCI for STEMI, post conditioning with cycles of balloon inflation/deflation within the first minute following the re-establishment of coronary blood blow, will decrease the amount of irreversible myocardial damage assessed by delayed enhancement contrast CMR.
Read the detailed description
In patients who suffer a myocardial infarction, the blood flow usually ceases due to plaque rupture leading to thrombus formation and vessel occlusion. The resultant entity is known as ST Elevation segment myocardial infarction (STEMI) and is a significant health issue in industrialized countries. There are over 50,000 STEMI's every year in Canada and up to 10% of these patients die in hospital and another 10% die within the first year after their heart attack. The more common problem however is not death, but irreparable damage to the left ventricle leading to LV dysfunction and subsequent heart failure and arrythmias. Re-establishing blood flow promptly by administering plasminogen activators (lytics) or mechanically by performing angioplasty is possible and has lowered the mortality rate dramatically.
Although reperfusion is necessary, it gives rise to an entity known as ischemia-reperfusion where acutely re-establishing blood flow and oxygen levels of the heart has detrimental effects. Clinically this is manifested as no-reflow that causes subsequent damage to the left ventricle and decreases the beneficial affect of early reperfusion by PCI. The ischemia-reperfusion effect sets off a molecular cascade of events involving unfavorable interaction between neutrophils, platelets and endothelium, that is fairly well identified. Efforts to pharmacologically block this effect have not proven to be particularly effective.
Post conditioning follows from a concept of pre-conditioning in animals that showed a decrease in myocardial infarct size. Pre-conditioning is not useful as it requires to be performed prior to the development of ischemia/injury. Post conditioning in preliminary studies with animals and one small study in humans have shown promising results for decrease in infarct size. Post conditioning is a procedure of gradual conditioning in which the artery is opened and closed in cycles with inflation/deflation of the culprit artery followed immediately by standard PCI and placement of stent.
- Conditions
- Myocardial Infarction
- Being tested
- Post conditioning
- Keywords
- Myocardial infarction, Magnetic Resonance Imaging, Coronary Angioplasty
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post conditioningProcedure or surgery
4 cycles of balloon inflation /deflation (post-conditioning) within first minute of opening up artery in primary PCI for STEMI vs usual balloon inflation sequence
| Study group | Role | What they receive |
|---|---|---|
| Post conditioning | Experimental | Balloon inflations-deflations Receives: Procedure: Post conditioning |
| Standard care | Placebo comparator | No balloon inflations Receives: Procedure: Post conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size as measured by: salvage index = total area at risk - infarct size/total area at risk
Measured: 3-5 days post MI
Secondary outcomes (11)
Corrected TIMI frame count (cTFC)
Measured: Immediately post PCI
Myocardial blush score
Measured: Immediately post PCI
CK release (under the curve)
Measured: 1st 48 hours post MI
ST segment resolution by 48 hrs compared with admission
Measured: 1st 48 hours post MI
MRI infarct size
Measured: 3-5 days and 6 months
MRI maximal transmural extent of irreversible injury
Measured: 3-5 days and 6 months
CMR regional end-systolic wall stress
Measured: 3-5 days and 6 months
CMR Myocardial perfusion
Measured: 3-5 days and 6 months
CMR Myocardial oxygenation
Measured: 3-5 days and 6 months
Peripheral endothelial function testing (brachial u/s and pulse arterial tonometry) in hospital
Measured: 3-5 days post MI
CMR quantification of volume of no-reflow
Measured: 3-5 days and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Foothills Interventional Cardiology Research Group
- Responsible party
- Principal investigator, Todd Anderson, University of Calgary
- Investigators
- Mouhieddin Traboulsi, MD, Study director, University of Calgary, sub-investigatorMatthias Friedrich, MD, Study chair, Sub-investigator, Stephenson CMR Centre, FMC; 1403-29th St NW, Calgary; T2N 2T9
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334373
- Sponsor's protocol ID
- Ethics ID E-20039
- Status last verified
- May 2015
- First submitted
- 6 Jun 2006
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Conditioning in PCI for Acute ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00334373
- Acronym / sponsor ID
- Ethics ID E-20039
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial infarction, Magnetic Resonance Imaging, Coronary Angioplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Foothills Interventional Cardiology Research Group
- Study start
- Jun 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 7 Jun 2006 (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 purpose of this trial is to compare post-conditioning to standard angioplasty (50/50 chance) in patients who present with an acute heart attack and are taken directly for an angioplasty procedure. Post conditioning is a procedure that involves balloon inflation followed by deflation in a series of cycles that appears to show (based on early data) that it can decrease the amount of damage to the heart muscle as compared to standard angioplasty procedures.
Hypothesis: For Subjects undergoing direct PCI for STEMI, post conditioning with cycles of balloon inflation/deflation within the first minute following the re-establishment of coronary blood blow, will decrease the amount of irreversible myocardial damage assessed by delayed enhancement contrast CMR.
Detailed description
In patients who suffer a myocardial infarction, the blood flow usually ceases due to plaque rupture leading to thrombus formation and vessel occlusion. The resultant entity is known as ST Elevation segment myocardial infarction (STEMI) and is a significant health issue in industrialized countries. There are over 50,000 STEMI's every year in Canada and up to 10% of these patients die in hospital and another 10% die within the first year after their heart attack. The more common problem however is not death, but irreparable damage to the left ventricle leading to LV dysfunction and subsequent heart failure and arrythmias. Re-establishing blood flow promptly by administering plasminogen activators (lytics) or mechanically by performing angioplasty is possible and has lowered the mortality rate dramatically.
Although reperfusion is necessary, it gives rise to an entity known as ischemia-reperfusion where acutely re-establishing blood flow and oxygen levels of the heart has detrimental effects. Clinically this is manifested as no-reflow that causes subsequent damage to the left ventricle and decreases the beneficial affect of early reperfusion by PCI. The ischemia-reperfusion effect sets off a molecular cascade of events involving unfavorable interaction between neutrophils, platelets and endothelium, that is fairly well identified. Efforts to pharmacologically block this effect have not proven to be particularly effective.
Post conditioning follows from a concept of pre-conditioning in animals that showed a decrease in myocardial infarct size. Pre-conditioning is not useful as it requires to be performed prior to the development of ischemia/injury. Post conditioning in preliminary studies with animals and one small study in humans have shown promising results for decrease in infarct size. Post conditioning is a procedure of gradual conditioning in which the artery is opened and closed in cycles with inflation/deflation of the culprit artery followed immediately by standard PCI and placement of stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post conditioning | Experimental | Procedure: Post conditioningBalloon inflations-deflations |
| Standard care | Placebo comparator | Procedure: Post conditioningNo balloon inflations |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and over
- ST elevation of >/= 2mm in 3 consecutive anterior leads or >/= to 2 mm in leads II, III and AVF with total 8 mm ST shift (ST depression of 1 mm in ant or lat leads)
Key exclusion criteria (8 listed)
- Cardiogenic shock or severe heart failure
- Inability to undergo CMR (metallic objects or claustrophobia)
- Previous MI
- TIMI 2-3 flow in target artery
- Collaterals to infarct related artery > Rentrop grade 1
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 |
|---|---|---|
| Post conditioning4 cycles of balloon inflation /deflation (post-conditioning) within first minute of opening up artery in primary PCI for STEMI vs usual balloon inflation sequence | Procedure or surgery | Post conditioning, Standard care |
Primary outcome
Infarct size as measured by: salvage index = total area at risk - infarct size/total area at risk
Time frame: 3-5 days post MI
11 secondary outcomes
Corrected TIMI frame count (cTFC)
Time frame: Immediately post PCI
Myocardial blush score
Time frame: Immediately post PCI
CK release (under the curve)
Time frame: 1st 48 hours post MI
ST segment resolution by 48 hrs compared with admission
Time frame: 1st 48 hours post MI
MRI infarct size
Time frame: 3-5 days and 6 months
MRI maximal transmural extent of irreversible injury
Time frame: 3-5 days and 6 months
CMR regional end-systolic wall stress
Time frame: 3-5 days and 6 months
CMR Myocardial perfusion
Time frame: 3-5 days and 6 months
CMR Myocardial oxygenation
Time frame: 3-5 days and 6 months
Peripheral endothelial function testing (brachial u/s and pulse arterial tonometry) in hospital
Time frame: 3-5 days post MI
CMR quantification of volume of no-reflow
Time frame: 3-5 days and 6 months
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 28 May 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.
Mouhieddin Traboulsi, MD study director
University of Calgary, sub-investigator
Matthias Friedrich, MD study chair
Sub-investigator, Stephenson CMR Centre, FMC; 1403-29th St NW, Calgary; T2N 2T9
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Post conditioning in people with Myocardial Infarction, run by University of Calgary at 1 site in Canada.
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 8 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 28 May 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Infarct size as measured by: salvage index = total area at risk - infarct size/total area at risk (time frame: 3-5 days post MI). 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 28 May 2015.