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CompletedNCT01324453Updated Jun 5, 2019Results posted

Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in ST-Elevation Myocardial Infarction (STEMI)

A Phase 1/2 interventional study of Post Conditioning + Primary PCI and Standard Primary PCI in Acute Myocardial Infarction, sponsored by Minneapolis Heart Institute Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-06-05.

Sponsored by Minneapolis Heart Institute Foundation · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Acute Myocardial Infarction

Keywords

  • Acute Myocardial Infarction
  • STEMI
  • Post Conditioning
  • Primary Percutaneous Coronary Intervention
03

In context

ST Elevation Myocardial Infarction

688 studies on the registry are indexed under ST Elevation Myocardial Infarction; 184 are open to participants now.

This study's enrollment of 103 is below the median of 194 across 439 interventional studies indexed under ST Elevation Myocardial Infarction.

Browse ST Elevation Myocardial Infarction studies →

Lead sponsor

Minneapolis Heart Institute Foundation is the lead sponsor of 34 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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)
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    Post conditioning + PCI

    Procedure: Post Conditioning + Primary PCI

  • Active comparator
    Standard PCI

    Procedure: Standard Primary PCI

Interventions

  • ProcedurePost Conditioning + Primary PCI

    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.

  • ProcedureStandard Primary PCI

    Routine Percutaneous Coronary Intervention as clinically indicated.

06

What researchers measure

Primary outcomes

  1. Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)

    Infarct size was quantified by delayed, contrast-enhanced MRI

    Time frame: Day 3-5 post-PCI

  2. 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.

    Time frame: Day 3-5 post-PCI

  3. Micro Vascular Obstruction (MVO) on Baseline cMRI

    High T1 imaging was utilized for the determination of the presence or absence of MVO.

    Time frame: Day 3-5 post-PCI

Secondary outcomes

  1. Global Left Ventricular Ejection Fraction

    Time frame: baseline

  2. Infarct Size by Peak Troponin

    Time frame: over first 72 hour post PCI

  3. Infarct Size by Peak Creatine Kinase (CK)

    Time frame: over first 72 hours post PCI

  4. 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.

    Time frame: baseline

  5. 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.

    Time frame: baseline

07

Results

Posted Apr 17, 2018

Participant flow

Participant flow — Overall Study
MilestonePost Conditioning + Percutaneous Coronary Intervertion (PCI)Standard Percutaneous Coronary Internvention (PCI)
Started5449
Completed5449
Not completed00

Outcome measures

PrimaryInfarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)

Infarct size was quantified by delayed, contrast-enhanced MRI

Time frame:
Day 3-5 post-PCI
Reported as:
Median · ml
Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)
mlPost Conditioning + PCIStandard PCI
Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)20.1 (12.8 to 30.2)21.0 (13.8 to 30.6)
Statistical analysis
  • Post Conditioning + PCI vs Standard PCI · Kruskal-Wallis · p = 0.90
PrimaryMyocardial 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.

Time frame:
Day 3-5 post-PCI
Reported as:
Median · (%)
Myocardial Salvage Index (MSI) on Baseline cMRI
(%)Post Conditioning + PCIStandard PCI
Myocardial Salvage Index (MSI) on Baseline cMRI32.6 (20.6 to 49.7)32.7 (22.2 to 46.4)
Statistical analysis
  • Post Conditioning + PCI vs Standard PCI · Kruskal-Wallis · p = 0.81
PrimaryMicro Vascular Obstruction (MVO) on Baseline cMRI

High T1 imaging was utilized for the determination of the presence or absence of MVO.

Time frame:
Day 3-5 post-PCI
Reported as:
Count of participants · Participants
Micro Vascular Obstruction (MVO) on Baseline cMRI
ParticipantsPost Conditioning + PCIStandard PCI
Micro Vascular Obstruction (MVO) on Baseline cMRI3125
Statistical analysis
  • Post Conditioning + PCI vs Standard PCI · Chi-squared · p = 0.45
SecondaryGlobal Left Ventricular Ejection Fraction
Time frame:
baseline
Reported as:
Mean · Percent
Global Left Ventricular Ejection Fraction
PercentPost Conditioning + PCIStandard PCI
Global Left Ventricular Ejection Fraction55.1 ± 10.854.0 ± 9.5
Statistical analysis
  • Post Conditioning + PCI vs Standard PCI · t-test, 2 sided · p = 0.58
SecondaryInfarct Size by Peak Troponin
Time frame:
over first 72 hour post PCI
Reported as:
Median · ng/ml
Infarct Size by Peak Troponin
ng/mlPost Conditioning + PCIStandard PCI
Infarct Size by Peak Troponin19.63 (3.55 to 72.36)14.44 (9.05 to 38.53)
Statistical analysis
  • Post Conditioning + PCI vs Standard PCI · Kruskal-Wallis · p = 0.86
SecondaryInfarct Size by Peak Creatine Kinase (CK)
Time frame:
over first 72 hours post PCI
Reported as:
Median · IU/L
Infarct Size by Peak Creatine Kinase (CK)
IU/LPost Conditioning + PCIStandard PCI
Infarct Size by Peak Creatine Kinase (CK)1701 (873 to 2854)1619 (801 to 2899)
Statistical analysis
  • Post Conditioning + PCI vs Standard PCI · Kruskal-Wallis · p = 1.00
SecondaryLeft 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.

Time frame:
baseline
Reported as:
Median · mL
Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl
mLPost Conditioning + PCIStandard PCI
Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl149 (138 to 172)147 (133 to 170)
Statistical analysis
  • Post Conditioning + PCI vs Standard PCI · Kruskal-Wallis · p = 0.58
SecondaryLeft 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.

Time frame:
baseline
Reported as:
Median · mL
Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl
mLPost Conditioning + PCIStandard PCI
Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl70 (51 to 81)65 (55 to 86)
Statistical analysis
  • Post Conditioning + PCI vs Standard PCI · Kruskal-Wallis · p = 0.77

Adverse events

Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Post Conditioning + PCI0/54 (0%)2/54 (3.7%)13/54 (24.1%)
Standard PCI1/49 (2%)2/49 (4.1%)7/49 (14.3%)
Most frequent serious events
Most frequent serious events
EventPost Conditioning + PCIStandard PCI
CVACardiac disorders0/541/49
Hospitalization readmission for Heart FailureCardiac disorders1/541/49
Acute Stent ThrombosisCardiac disorders1/540/49
Most frequent other events
Most frequent other events
EventPost Conditioning + PCIStandard PCI
Groin hematomaVascular disorders2/543/49
Non-cardiac chest painMusculoskeletal and connective tissue disorders3/540/49
NSVTCardiac disorders3/540/49
Atriall Fibrillation/FlutterCardiac disorders2/542/49
Chest PainCardiac disorders1/542/49
VF/VTCardiac disorders2/541/49

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Post Conditioning + PCIStandard PCITotal
Mean59.8 ± 10.060.0 ± 9.759.9 ± 9.8
Sex: Female, Male
Sex: Female, Male(Participants)Post Conditioning + PCIStandard PCITotal
Female61016
Male483987
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Post Conditioning + PCIStandard PCITotal
American Indian or Alaska Native011
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American415
White484694
More than one race000
Unknown or Not Reported112
Diabetes
Diabetes(Participants)Post Conditioning + PCIStandard PCITotal
Diabetes10919
No Diabetes444084
Hypertension
Hypertension(Participants)Post Conditioning + PCIStandard PCITotal
Hypertension292251
No Hypertension252752
Hyperlipidemia
Hyperlipidemia(Participants)Post Conditioning + PCIStandard PCITotal
Dyslipidemia332659
No Dylsipidemia212344
Current Smoker
Current Smoker(Participants)Post Conditioning + PCIStandard PCITotal
Yes283058
No261844
Unknown011
History of Stroke
History of Stroke(Participants)Post Conditioning + PCIStandard PCITotal
Yes101
No5349102

4 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
09

References and documents

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 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2011, a primary completion of Nov 2016 and a completion of Mar 2017. It does not say whether these dates are actual or estimated.

Results were first posted in Apr 2018, 1 year 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2011
First posted
Mar 29, 2011
Start
Mar 2011
Primary completionActual
Nov 2016
CompletionActual
Mar 2017
Results first posted
Apr 17, 2018
Last update
Jun 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01324453
Lead sponsor
Minneapolis Heart Institute Foundation
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Mar 29, 2011
Start date
Mar 2011
Primary completion
Nov 2016
Completion
Mar 2017
Results posted
Apr 17, 2018
Last update
Jun 5, 2019

Study contacts

Jay H Traverse, MD
principal investigator · Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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