NCT01324453

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 17, 2018

Completed
Last Updated

June 5, 2019

Status Verified

May 1, 2019

Enrollment Period

5.7 years

First QC Date

March 25, 2011

Results QC Date

March 16, 2018

Last Update Submit

May 22, 2019

Conditions

Acute Myocardial Infarction

Keywords

Acute Myocardial InfarctionSTEMIPost ConditioningPrimary Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (3)

  • Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)

    Infarct size was quantified by delayed, contrast-enhanced MRI

    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.

    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.

    Day 3-5 post-PCI

Secondary Outcomes (5)

  • Global Left Ventricular Ejection Fraction

    baseline

  • Infarct Size by Peak Troponin

    over first 72 hour post PCI

  • Infarct Size by Peak Creatine Kinase (CK)

    over first 72 hours post PCI

  • Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl

    baseline

  • Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl

    baseline

Study Arms (2)

Post conditioning + PCI

EXPERIMENTAL
Procedure: Post Conditioning + Primary PCI

Standard PCI

ACTIVE COMPARATOR
Procedure: Standard Primary PCI

Interventions

Post Conditioning + Primary PCIPROCEDURE

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.

Post conditioning + PCI
Standard Primary PCIPROCEDURE

Routine Percutaneous Coronary Intervention as clinically indicated.

Standard PCI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (1)

  • 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.

    PMID: 30602360DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title
Jane Fox
Organization
Minneapolis Heart Institute Foundation
jane.fox@allina.com
6128636289

Study Officials

  • Jay H Traverse, MD

    Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2011

First Posted

March 29, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2016

Study Completion

March 1, 2017

Last Updated

June 5, 2019

Results First Posted

April 17, 2018

Record last verified: 2019-05

Locations

US(1)