Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention (PCI) (RemPostCon)
Primary Purpose
Myocardial Reperfusion Injury, Myocardial Ischemia, Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Remote Postconditioning
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Reperfusion Injury focused on measuring Remote Postconditioning, Myocardial reperfusion Injury, Myocardial Infarction, Primary PCI
Eligibility Criteria
Inclusion Criteria:
- Age >= 18 yrs AND Age =< 80 yrs
- STEMI definition
- Pain to door time < 6 hrs
- Killip class 1 - 2 - 3
- Initial TIMI flow 0 - 1 in the anterior descending artery
- Signed informed consent
Exclusion Criteria:
- Pregnancy
- Cardiogenic shock
- Initial TIMI flow 2 - 3 in the anterior descending artery
- History of prior MI in the past 6 months
- History of prior CABG
- History of peripheral vascular disease III - IV grade
- History of abdominal Aortic Aneurysm > 5 cm
- Severe coronaropathy that could condition further revascularization before the end of the study
- Other relevant medical or surgical conditions that can influence prognosis at 4 months
Sites / Locations
- ASL3 Genovese, Villa Scassi Hospitale
- IRCCS Policlinico San Matteo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
RemotePostConditioning
Controls
Arm Description
Patients will receive pPCI and treatments according to guidelines for STEMI PLUS extrinsic cuff compression to the lower limb for 5 ' followed by 5' reperfusion for three cycles (30' in total) starting with myocardial reperfusion
pPCI and treatments according to guidelines for STEMI
Outcomes
Primary Outcome Measures
Area Under the Curve of CK - MB release
Secondary Outcome Measures
Area Under the Curve of CK release
TIMI Frame Count
Time to balloon
Ejection Fraction MRI
Myocardial Blush grading
ST segment resolution
Troponin I peak
Mortality rate
artero-venous differences in pO2, pCO2, pH, HCo3
Major adverse cardiac events
artero-venous quantitative and qualitative differences in endothelial progenitors cells (subgroups)
artero-venous Differences of Cytokines
Edema Volume T2 sequences MRI
Delay enhancement volume MRI
Full Information
NCT ID
NCT00865722
First Posted
March 18, 2009
Last Updated
August 16, 2012
Sponsor
IRCCS Policlinico S. Matteo
1. Study Identification
Unique Protocol Identification Number
NCT00865722
Brief Title
Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention (PCI)
Acronym
RemPostCon
Official Title
Pilot Study to Test Feasibility, Safety, Molecular Mediators and Preliminary Efficacy of Remote Myocardial Postconditioning Provided With Extrinsic Cuff Compression of Lower Limb During Primary PCI
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Experimental studies suggest that remote limb ischaemic postconditioning (RemPostCon) can reduce infarct size in pigs. Initial clinical applications support the beneficial role of RemPostCon in preserving endothelial function during upper limb ischemia in healthy volunteers and in patients with stable coronary artery disease.
Aim of the study: To evaluate the feasibility, safety and efficacy of RemPostCon in the setting of STEMI and primary PCI (pPCI) and to investigate potential circulating mediators of its effects.
Patients and methods: Patients who undergo pPCI for anterior STEMI within 6 hours since the onset of symptoms are randomly assigned to receive either RemPostCon + pPCI or pPCI alone in a single-blind fashion. All patients receive therapy according to the current international guidelines. Three cycles of ischemia-reperfusion are provided to the lower limb inflating a cuff to 200 mmHg. Each cycle consists of 5' of ischaemia, followed by 5' of reperfusion. RemPostCon is started at the time of angioplasty in the infarct related artery. Primary endpoint is the area under the curve (AUC) of creatinine kinase - MB (CK - MB). Cardiac magnetic resonance (CMR) is performed early before discharge and 4 months after the event, if there are no contraindications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Reperfusion Injury, Myocardial Ischemia, Myocardial Infarction
Keywords
Remote Postconditioning, Myocardial reperfusion Injury, Myocardial Infarction, Primary PCI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RemotePostConditioning
Arm Type
Active Comparator
Arm Description
Patients will receive pPCI and treatments according to guidelines for STEMI PLUS extrinsic cuff compression to the lower limb for 5 ' followed by 5' reperfusion for three cycles (30' in total) starting with myocardial reperfusion
Arm Title
Controls
Arm Type
Sham Comparator
Arm Description
pPCI and treatments according to guidelines for STEMI
Intervention Type
Procedure
Intervention Name(s)
Remote Postconditioning
Intervention Description
Lower limb compression using a cuff inflated to 200 mmHg for 5 ' followed by 5' of reperfusion fo three times during 30'
Primary Outcome Measure Information:
Title
Area Under the Curve of CK - MB release
Time Frame
baseline to 72h since admission
Secondary Outcome Measure Information:
Title
Area Under the Curve of CK release
Time Frame
baselinte to 72h since admission
Title
TIMI Frame Count
Time Frame
30 minutes after first balloon inflation in infarct-related artery
Title
Time to balloon
Time Frame
during pPCI
Title
Ejection Fraction MRI
Time Frame
before discharge and after 4 months
Title
Myocardial Blush grading
Time Frame
30 minutes after first balloon inflation
Title
ST segment resolution
Time Frame
6h after balloon
Title
Troponin I peak
Time Frame
72h since admission
Title
Mortality rate
Time Frame
4 months since admission
Title
artero-venous differences in pO2, pCO2, pH, HCo3
Time Frame
baseline and 30 minutes after first balloon inflation
Title
Major adverse cardiac events
Time Frame
4 months since admission
Title
artero-venous quantitative and qualitative differences in endothelial progenitors cells (subgroups)
Time Frame
within 24 h since admission
Title
artero-venous Differences of Cytokines
Time Frame
within 24h since admission
Title
Edema Volume T2 sequences MRI
Time Frame
before discharge
Title
Delay enhancement volume MRI
Time Frame
before discharge and after 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >= 18 yrs AND Age =< 80 yrs
STEMI definition
Pain to door time < 6 hrs
Killip class 1 - 2 - 3
Initial TIMI flow 0 - 1 in the anterior descending artery
Signed informed consent
Exclusion Criteria:
Pregnancy
Cardiogenic shock
Initial TIMI flow 2 - 3 in the anterior descending artery
History of prior MI in the past 6 months
History of prior CABG
History of peripheral vascular disease III - IV grade
History of abdominal Aortic Aneurysm > 5 cm
Severe coronaropathy that could condition further revascularization before the end of the study
Other relevant medical or surgical conditions that can influence prognosis at 4 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Ferrario, MD
Organizational Affiliation
IRCCS Policlinico San Matteo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gabriele Crimi, MD
Organizational Affiliation
IRCCS Policlinico San Matteo
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASL3 Genovese, Villa Scassi Hospitale
City
Genoa
ZIP/Postal Code
16100
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
24156966
Citation
Crimi G, Pica S, Raineri C, Bramucci E, De Ferrari GM, Klersy C, Ferlini M, Marinoni B, Repetto A, Romeo M, Rosti V, Massa M, Raisaro A, Leonardi S, Rubartelli P, Oltrona Visconti L, Ferrario M. Remote ischemic post-conditioning of the lower limb during primary percutaneous coronary intervention safely reduces enzymatic infarct size in anterior myocardial infarction: a randomized controlled trial. JACC Cardiovasc Interv. 2013 Oct;6(10):1055-63. doi: 10.1016/j.jcin.2013.05.011.
Results Reference
derived
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Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention (PCI)
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