Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention (PCI)
RemPostCon
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
1 other identifier
interventional
96
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2009
Typical duration for phase_2
2 active sites
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, 2009
CompletedFirst Submitted
Initial submission to the registry
March 18, 2009
CompletedFirst Posted
Study publicly available on registry
March 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedAugust 17, 2012
August 1, 2012
3.2 years
March 18, 2009
August 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under the Curve of CK - MB release
baseline to 72h since admission
Secondary Outcomes (14)
Area Under the Curve of CK release
baselinte to 72h since admission
TIMI Frame Count
30 minutes after first balloon inflation in infarct-related artery
Time to balloon
during pPCI
Ejection Fraction MRI
before discharge and after 4 months
Myocardial Blush grading
30 minutes after first balloon inflation
- +9 more secondary outcomes
Study Arms (2)
RemotePostConditioning
ACTIVE COMPARATORPatients 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
Controls
SHAM COMPARATORpPCI and treatments according to guidelines for STEMI
Interventions
Lower limb compression using a cuff inflated to 200 mmHg for 5 ' followed by 5' of reperfusion fo three times during 30'
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
IRCCS Policlinico San Matteo
Pavia, Italy, 27100, Italy
ASL3 Genovese, Villa Scassi Hospitale
Genoa, 16100, Italy
Related Publications (1)
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.
PMID: 24156966DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maurizio Ferrario, MD
IRCCS Policlinico San Matteo
- PRINCIPAL INVESTIGATOR
Gabriele Crimi, MD
IRCCS Policlinico San Matteo
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 18, 2009
First Posted
March 19, 2009
Study Start
March 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
August 17, 2012
Record last verified: 2012-08