Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction

Coronary Artery Disease Clinical Trial

— RECOND  

Official title:

Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction in Stockholm (RECOND)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021760
• Other study ID #: RECOND
• Status: Completed
• Phase: N/A
• First received: December 20, 2013
• Last updated: February 8, 2016
• Start date: May 2013
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

• Trial objective: To test the hypothesis that remote per-postconditioning in connection with primary PCI will reduce myocardial infarct size patients with STEMI.

• Trial Design: Placebo controlled randomized study with parallel groups

• Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance (CMR) day 4-7

• Efficacy Parameters: Myocardial infarct size expressed as a percentage to the myocardium at risk determined by CMR at 6 months.

• Global left ventricular function determined by left ventricular ejection fraction determined by CMR.

• Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day 180.

• Safety Parameters: Major adverse cardiovascular events.

Description:

See above. 3 patients left to include.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient planned for primary PCI.

• Chest pain indicating myocardial ischemia with a duration >30 minutes and < 6 hours prior to randomization.

• ST elevations >0.1 mV (>0.2 mV in V2-V3) in > two contiguous leads in V1-V6.

• Informed consent.

Exclusion Criteria:

• Previous myocardial infarction based on medical history or Q-wave on ECG in other area

• Left Bundle Branch Block on ECG.

• Previous CABG

• Cardiac arrest

• Any contraindication for CMR.

• Clinical symptoms of claudication

• Treatment with glibenclamide or cyclosporine on admission.

• Any condition that may interfere with the possibility for the patient to comply with or complete the study protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Procedure:
• Primary Percutaneous Coronary Intervention
Primary Percutanous Coronary Intervention is performed in both Groups.

Locations

Country	Name	City	State
Sweden	Danderyds Hospital	Stockholm
Sweden	Karolinska University Hospital	Stockholm
Sweden	Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
John Pernow

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global left ventricular function determined by left ventricular ejection fraction determined by CMR.		4-7 days and 6 months following index event	No
Other	Microvascular obstruction determined by CMR		4-7 days following index event	No
Other	Quantified ECV (extracellular volume) in left ventricular as myocardium at risk		4-7 days following index event	No
Other	Myocardial infarct size by CMR expressed as a percentage to the myocardium at risk determined by Bari or modified Approach Score with coronary angiography.		5-7 days following index event	No
Primary	Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance		4-7 days following index event	No
Secondary	Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance		6 months following index event	No