Acute Myocardial InfarctionPhase 1/2NCT01324453
Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in ST-Elevation Myocardial Infarction (STEMI)
A Phase 1/2 study testing Post Conditioning + Primary PCI and Standard Primary PCI in people with Acute Myocardial Infarction, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial summary
This study will evaluate change in heart muscle function from baseline to three months and twelve months in participants who present with a heart attack and a completely occluded coronary artery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Post Conditioning + Primary PCI and Standard Primary PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age > 18 years old, < 80 years old
- Able to give informed consent
- Able to undergo cMRl (cardiac magnetic resonance imaging
- ST-segment elevation infarction with 100% occlusion of a major epicardial vessel (> 2.5 mm)
- No angiographic evidence of collateral flow distal to occluded artery
- Ischemic duration between 1.0 and 6 hours
- Thrombolysis in myocardial infarction (TIMI) 3 Flow following PCI
Who cannot join
- Visible collateral blood flow to the distal vasculature of the occluded vessel
- Previous Coronary Artery Bypass Graft surgery
- Previous q-wave myocardial infarction in the same territory
- Inability to give informed consent
- Inability to undergo cMRl
- Life expectancy less than one year
Show all 13Show fewer
- History of Non-compliance or alcohol or drug addiction
- Patients with cardiogenic shock, cardiac arrest, hypothermia on presentation
- Chronic dialysis or significant renal insufficiency (Creatinine Clearance < 35 mI/mm/i .73 m2)
- TIMI Flow > 0 on presentation
- Ischemic Time > 6 hours or < 1.0 hours
- Presence of significant valvular heart disease (>mod Aortic Stenosis, >2+ Mitral Regurgitation)
- Known Left Ventricular systolic dysfunction (Left Ventricular Ejection Fraction < 50% prior to STEMI)
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
Official title: Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in STEMI
This study will evaluate change in heart muscle function from baseline to three months and twelve months in participants who present with a heart attack and a completely occluded coronary artery. These subjects will be randomized to receive standard Percutaneous transluminal coronary angioplasty (PTCA)/Stenting to open the artery or routine PTCA/Stenting plus post conditioning. Post conditioning commences immediately upon reperfusion using four cycles of thirty second inflations with a standard angioplasty balloon followed by a thirty seconds of reperfusion. The investigators hypothesize that Postconditioning reduces the size of the heart attack when utilized with successful primary Angioplasty/stent.
Read the detailed description
Single center study involving 140 patients randomized to Post Conditioning + Percutaneous coronary intervention (PCI) versus routine PCI during their ST-Elevation Myocardial Infarction (STEMI, Heart Attack) presentation. The Post Conditioning protocol consists of performing four, 30-second PTCA (Angioplasty) balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes. The first balloon inflation occurs immediately after an angioplasty guidewire is placed through the obstruction in the artery. Following this protocol the vessel is stented as part of the usual practice for treatment of STEMI. No other treatment differences will occur between the two groups and all patients will receive the usual post-STEMI care. Patients in both groups will receive a cardiac MRI 3-5 days following their STEMI for measurement of heart attack size and heart muscle function, among other measures. Patients will undergo collection of blood for creatine kinase (CK)-MB and troponin I every 8 hours for 24 hours following PCI. All patients will be followed by phone follow-up visits to review history and major adverse cardiac event (MACE) (death, recurrent STEMI, repeat revascularization, arrhythmias, implantable cardioverter-defibrillator (ICD) placement and hospitalization for congestive heart failure (CHF)). All patients will be required to take P2Y12 inhibitors and aspirin for the duration of the trial. All patients will be treated with angiotensin-converting enzyme inhibitor (ACE-I), beta blockers and statins.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Post Conditioning + Primary PCI, Standard Primary PCI
- Keywords
- Acute Myocardial Infarction, STEMI, Post Conditioning, Primary Percutaneous Coronary Intervention
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Conditioning + Primary PCIProcedure or surgery
Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
Standard Primary PCIProcedure or surgery
Routine Percutaneous Coronary Intervention as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Post conditioning + PCI | Experimental | Not described Receives: Procedure: Post Conditioning + Primary PCI |
| Standard PCI | Active comparator | Not described Receives: Procedure: Standard Primary PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)
Infarct size was quantified by delayed, contrast-enhanced MRI
Measured: Day 3-5 post-PCI
Myocardial Salvage Index (MSI) on Baseline cMRI
The myocardial salvage index (MSI) was calculated using the formula: MSI = (AAR - Infarct size) / AAR X 100 % where quantitative estimation of myocardium at risk (AAR) was measured as the hyperintense region on T2- weighted imaging. Measurements were performed using the QMass software package (Medis mc, Raleigh NC) by a single investigator who was blinded to treatment. The endocardial and epicardial borders were manually identified and the regions of interest (edema or scar) were automated as 2 standard deviations above the mean density of the myocardium.
Measured: Day 3-5 post-PCI
Micro Vascular Obstruction (MVO) on Baseline cMRI
High T1 imaging was utilized for the determination of the presence or absence of MVO.
Measured: Day 3-5 post-PCI
Secondary outcomes (5)
Global Left Ventricular Ejection Fraction
Measured: baseline
Infarct Size by Peak Troponin
Measured: over first 72 hour post PCI
Infarct Size by Peak Creatine Kinase (CK)
Measured: over first 72 hours post PCI
Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl
LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole.
Measured: baseline
Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl
LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jay H Traverse, MD, Principal investigator, Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324453
- Sponsor's protocol ID
- opt004
- Other IDs
- 1R01HL103927-01A1
- Status last verified
- May 2019
- First submitted
- 25 Mar 2011
- Last updated
- 5 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Traverse JH, Swingen CM, Henry TD, Fox J, Wang YL, Chavez IJ, Lips DL, Lesser JR, Pedersen WR, Burke NM, Pai A, Lindberg JL, Garberich RF. NHLBI-Sponsored Randomized Trial of Postconditioning During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction. Circ Res. 2019 Mar;124(5):769-778. doi: 10.1161/CIRCRESAHA.118.314060.
PubMed 30602360
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in STEMI
- ClinicalTrials.gov ID
- NCT01324453
- Acronym / sponsor ID
- opt004
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, STEMI, Post Conditioning, Primary Percutaneous Coronary Intervention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Posted 17 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate change in heart muscle function from baseline to three months and twelve months in participants who present with a heart attack and a completely occluded coronary artery. These subjects will be randomized to receive standard Percutaneous transluminal coronary angioplasty (PTCA)/Stenting to open the artery or routine PTCA/Stenting plus post conditioning. Post conditioning commences immediately upon reperfusion using four cycles of thirty second inflations with a standard angioplasty balloon followed by a thirty seconds of reperfusion. The investigators hypothesize that Postconditioning reduces the size of the heart attack when utilized with successful primary Angioplasty/stent.
Detailed description
Single center study involving 140 patients randomized to Post Conditioning + Percutaneous coronary intervention (PCI) versus routine PCI during their ST-Elevation Myocardial Infarction (STEMI, Heart Attack) presentation. The Post Conditioning protocol consists of performing four, 30-second PTCA (Angioplasty) balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes. The first balloon inflation occurs immediately after an angioplasty guidewire is placed through the obstruction in the artery. Following this protocol the vessel is stented as part of the usual practice for treatment of STEMI. No other treatment differences will occur between the two groups and all patients will receive the usual post-STEMI care. Patients in both groups will receive a cardiac MRI 3-5 days following their STEMI for measurement of heart attack size and heart muscle function, among other measures. Patients will undergo collection of blood for creatine kinase (CK)-MB and troponin I every 8 hours for 24 hours following PCI. All patients will be followed by phone follow-up visits to review history and major adverse cardiac event (MACE) (death, recurrent STEMI, repeat revascularization, arrhythmias, implantable cardioverter-defibrillator (ICD) placement and hospitalization for congestive heart failure (CHF)). All patients will be required to take P2Y12 inhibitors and aspirin for the duration of the trial. All patients will be treated with angiotensin-converting enzyme inhibitor (ACE-I), beta blockers and statins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post conditioning + PCI | Experimental | Procedure: Post Conditioning + Primary PCI |
| Standard PCI | Active comparator | Procedure: Standard Primary PCI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years old, < 80 years old
- Able to give informed consent
- Able to undergo cMRl (cardiac magnetic resonance imaging
- ST-segment elevation infarction with 100% occlusion of a major epicardial vessel (> 2.5 mm)
- No angiographic evidence of collateral flow distal to occluded artery
Key exclusion criteria (13 listed)
- Visible collateral blood flow to the distal vasculature of the occluded vessel
- Previous Coronary Artery Bypass Graft surgery
- Previous q-wave myocardial infarction in the same territory
- Inability to give informed consent
- Inability to undergo cMRl
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 Conditioning + Primary PCIFour, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated. | Procedure or surgery | Post conditioning + PCI |
| Standard Primary PCIRoutine Percutaneous Coronary Intervention as clinically indicated. | Procedure or surgery | Standard PCI |
Primary outcome
Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)
Time frame: Day 3-5 post-PCI
Infarct size was quantified by delayed, contrast-enhanced MRI
Myocardial Salvage Index (MSI) on Baseline cMRI
Time frame: Day 3-5 post-PCI
The myocardial salvage index (MSI) was calculated using the formula: MSI = (AAR - Infarct size) / AAR X 100 % where quantitative estimation of myocardium at risk (AAR) was measured as the hyperintense region on T2- weighted imaging. Measurements were performed using the QMass software package (Medis mc, Raleigh NC) by a single investigator who was blinded to treatment. The endocardial and epicardial borders were manually identified and the regions of interest (edema or scar) were automated as 2 standard deviations above the mean density of the myocardium.
Micro Vascular Obstruction (MVO) on Baseline cMRI
Time frame: Day 3-5 post-PCI
High T1 imaging was utilized for the determination of the presence or absence of MVO.
5 secondary outcomes
Global Left Ventricular Ejection Fraction
Time frame: baseline
Infarct Size by Peak Troponin
Time frame: over first 72 hour post PCI
Infarct Size by Peak Creatine Kinase (CK)
Time frame: over first 72 hours post PCI
Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl
Time frame: baseline
Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30602360Traverse JH, Swingen CM, Henry TD, Fox J, Wang YL, Chavez IJ, Lips DL, Lesser JR, Pedersen WR, Burke NM, Pai A, Lindberg JL, Garberich RF. NHLBI-Sponsored Randomized Trial of Postconditioning During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction. Circ Res. 2019 Mar;124(5):769-778. doi: 10.1161/CIRCRESAHA.118.314060.
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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.
Jay H Traverse, MD principal investigator
Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Post Conditioning + Primary PCI and Standard Primary PCI in people with Acute Myocardial Infarction, run by Minneapolis Heart Institute Foundation at 1 site in United States.
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 7 inclusion and 13 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 5 Jun 2019. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 on Baseline Cardiac Magnetic Resonance Imaging (cMRI) (time frame: Day 3-5 post-PCI). 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?
On the ClinicalTrials.gov record for NCT01324453, 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 5 Jun 2019.