Back to resultsMinimizing Reperfusion Injury in Patients With Acute Myocardial Infarction (PCinAMI)
Primary Purpose
Acute Myocardial Infarction
Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Post conditioning
Usual Care for STEMI
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring ST segment elevation myocardial infarction (STEMI), timed balloon inflations, post conditioning
Eligibility Criteria
Inclusion Criteria:
- STEMI
- Onset of symptoms within 6 hours
- TIMI 0 to TIMI 1 flow in infarct related artery
Exclusion Criteria:
- collaterals to infarct related artery
- previous infarct in related territory
- thrombolytics
- cardiogenic shock
- TIMI 2 to TIMI 3 flow
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Post conditioning
Usual Care
Arm Description
After 30 seconds of re-established coronary flow following the therapeutic balloon dilatation and deflation, the same balloon will be re-inflated for 30 seconds and then again deflated for 30 seconds. The balloon should be inflated to only occlude the coronary artery. This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.
Usual care for treatment of thrombolysis in myocardial infarction (TIMI) 0 to TIMI 1 flow in occluded infarct related artery. Usual care includes reperfusion of the artery per operator discretion, i.e. primary stenting, thrombectomy, balloon inflation/deflation without timed intervals.
Outcomes
Primary Outcome Measures
Quantitation of infarct size will be done using a modification of University Hospital's standard Single-photon emission computed tomography (SPECT) quantitation software
Echocardiograms will be analyzed to evaluate left ventricular function. Standard techniques will be used to quantitate ejection fraction and the percentage of left ventricular circumference that is hypokinetic or dyskinetic.
Venous blood samples troponin, creatine phosphokinase (CPK). This will be done to follow enzyme release and washout, and area data will be available and infarct size/risk area ratios in control and post-conditioning subjects will be compared.
ECG ST segment resolution immediate post percutaneous coronary intervention(PCI), and daily x 3.
Secondary Outcome Measures
Full Information
NCT ID
NCT00846378
First Posted
April 16, 2008
Last Updated
January 31, 2014
Sponsor
University of Cincinnati
Collaborators
Cardiology Research UBC
1. Study Identification
Unique Protocol Identification Number
NCT00846378
Brief Title
Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction
Acronym
PCinAMI
Official Title
The Mechanism of Ischemic Post-conditioning in Humans: Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Suspended
Why Stopped
Suspended for potential change in protocol to include different imaging modalities
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Cardiology Research UBC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The size of a heart attack will be decreased by the use of timed balloon inflations to open the blocked blood vessel.
Detailed Description
The intervention of "post conditioning" at the time of reperfusion, in patients with acute myocardial infarction (AMI), will attenuate the degree of ischemia-reperfusion injury, as manifested by infarct size. This intervention is hypothesized to be safe in humans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
ST segment elevation myocardial infarction (STEMI), timed balloon inflations, post conditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Post conditioning
Arm Type
Experimental
Arm Description
After 30 seconds of re-established coronary flow following the therapeutic balloon dilatation and deflation, the same balloon will be re-inflated for 30 seconds and then again deflated for 30 seconds. The balloon should be inflated to only occlude the coronary artery. This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care for treatment of thrombolysis in myocardial infarction (TIMI) 0 to TIMI 1 flow in occluded infarct related artery. Usual care includes reperfusion of the artery per operator discretion, i.e. primary stenting, thrombectomy, balloon inflation/deflation without timed intervals.
Intervention Type
Procedure
Intervention Name(s)
Post conditioning
Intervention Description
after 30 seconds of re-established coronary flow following the therapeutic balloon dilatation and deflation, the same balloon will be re-inflated for 30 seconds and then again deflated for 30 seconds. This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.
Intervention Type
Procedure
Intervention Name(s)
Usual Care for STEMI
Intervention Description
Usual care for treatment of TIMI 0 to TIMI 1 flow in occluded infarct related artery. Usual care includes reperfusion of the artery per operator discretion, i.e. primary stenting, thrombectomy, balloon inflation/deflation without timed intervals.
Primary Outcome Measure Information:
Title
Quantitation of infarct size will be done using a modification of University Hospital's standard Single-photon emission computed tomography (SPECT) quantitation software
Time Frame
6 weeks
Title
Echocardiograms will be analyzed to evaluate left ventricular function. Standard techniques will be used to quantitate ejection fraction and the percentage of left ventricular circumference that is hypokinetic or dyskinetic.
Time Frame
6 weeks
Title
Venous blood samples troponin, creatine phosphokinase (CPK). This will be done to follow enzyme release and washout, and area data will be available and infarct size/risk area ratios in control and post-conditioning subjects will be compared.
Time Frame
baseline, every 8 hours x 3
Title
ECG ST segment resolution immediate post percutaneous coronary intervention(PCI), and daily x 3.
Time Frame
baseline, up to 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
STEMI
Onset of symptoms within 6 hours
TIMI 0 to TIMI 1 flow in infarct related artery
Exclusion Criteria:
collaterals to infarct related artery
previous infarct in related territory
thrombolytics
cardiogenic shock
TIMI 2 to TIMI 3 flow
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Helmy, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
12. IPD Sharing Statement
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Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction
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