Remote Ischemic Conditioning in STEMI to Decrease Infarct Size

STEMI Clinical Trial

— RemCon-STEMI  

Official title:

A Multi-center Randomized Trial of Remote Ischemic Conditioning to Reduce Infarct Size in Patients With an ST-Elevation Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930589
• Other study ID #: V1 November 15, 2013
• Status: Completed
• Phase: N/A
• Start date: November 8, 2013
• Est. completion date: November 26, 2018

Study information

• Verified date: April 2019
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Following acute STEMI patients may have significant myocardial damage and subsequent heart failure. There is currently conflicting data regarding the benefit of remote ischemic conditioning to decrease the magnitude of infarction. Remote ischemic condition is a process where by repetitive intermittent limb ischemia is used to decrease the magnitude of myocardial damage caused by coronary artery occlusion and the subsequent reperfusion injury in STEMI patients. RemCon-STEMI is a multicenter randomized trial to test the impact of remote ischemic conditioning in acute STEMI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: November 26, 2018
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients presenting with STEMI within 6 hours of symptom onset and:

1. Are expected to receive reperfusion therapy with either fibrinolysis or primary PCI.

2. Documented informed consent (verbal)

Exclusion Criteria:

1. Cardiogenic shock

2. History of anatomical deformity or vascular complication that limit ability to conduct remote ischemic preconditioning

Related Conditions & MeSH terms

• CAD
• ST Elevation Myocardial Infarction
• STEMI

Intervention

Procedure:
• Remote Ischemic conditioning
BP cuff inflation for 5 min and deflation for 5 mins with 4 cycles

Other:
• Standard of care
Standard of care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian VIGOUR Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all cause death	all cause death, cardiogenic shock or chf through 90 days	90 days
Secondary	long term survival	survival	up to 1 year
Secondary	myocardial infarction size	mi size using peak elevation of cardiac biomarkers	within 72 hours of hospital admission
Secondary	ECG infarct size	QRS score on baseline and discharge ECGS	with 10 days or hospital discharge whichever occurs first
Secondary	Reperfusion	ST segment resolution 30 minutes post PCI	within 24 hours of admission to hospital