Effect of Remote Ischemic Conditioning in Heart Attack Patients

ST-segment Elevation Myocardial Infarction (STEMI) Clinical Trial

— ERIC-LYSIS  

Official title:

Effect of Remote Ischaemic Conditioning in STEMI Patients Treated by thromboLYSIS: A Randomised Controlled Clinical Trial (the ERIC-LYSIS Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197117
• Other study ID #: ERIC-LYSIS
• Status: Completed
• Phase: N/A
• First received: July 18, 2014
• Last updated: May 7, 2017
• Start date: March 2011
• Est. completion date: August 2014

Study information

• Verified date: May 2017
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

New treatments are required to improve health outcomes in patients with ischemic heart disease. This is especially so in developing countries such as Mauritius in which optimal therapy for acute myocardial infarction may not be widely available. For example for patients presenting with a heart attack (caused by a blockage in one of the heart blood vessels) the treatment of choice would be to remove the blockage by primary percutaneous coronary intervention (PCI) using an angioplasty balloon and put a stent (a spring-like structure) to keep the artery opened. However, PCI is not widely available in Mauritius and heart attack patients are given clot-busting therapy to remove the blockage, but this is not as effective as PCI.

Therefore, in this research study we investigate a new cheap treatment that may help protect the heart against damage during a heart attack, called remote ischemic conditioning (RIC), in which a blood pressure cuff is placed on the upper arm and inflated for 5 minute and deflated for 5 minutes a cycle which is repeated 4 times in total in patients presenting with a heart attack. By temporarily depriving oxygen and nutrients to the arm with the blood pressure cuff a protective signal can be relayed to the heart to reduce the amount of damage occurring during the heart attack and thereby prevent the onset of heart failure.

Study hypothesis: Remote ischaemic conditioning will reduce the amount of damage occurring to the heart muscle during a heart attack..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 519
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Presentation within 12 hours of onset of chest pain

• ECG showing ST-segment elevation of =0.1mV in two contiguous leads (=0.2mV in leads V1-V3)

Exclusion Criteria:

-None -

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-segment Elevation Myocardial Infarction (STEMI)

Intervention

Device:
• Remote ischemic conditioning

• Control

Locations

Country	Name	City	State
Mauritius	Victoria Hospital	Candos
Mauritius	Flacq Hospital	Flacq
Mauritius	Sir Seewoosagur Ramgoolam National Hospital	Pamplemousses
Mauritius	Dr AG Jeetoo Hospital	Port Louis
Mauritius	Jawaharlal Nehru Hospital	Rose-Belle

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

Mauritius, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial infarct size	Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis.	Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis
Secondary	Acute kidney injury	Measured by serum creatinine at 24 hours.	Measured by serum creatinine at 24 hours