Remote Ischaemic Postconditioning in the Clinical Setting of NSTEACS and Urgent PCI

Post Procedural Myocardial Infarction Clinical Trial

Official title:

A Study Investigating the Cardioprotective Benefits of Remote Ischaemic Postconditioning in Patients Presenting With Non ST Elevation Acute Coronary Syndromes Undergoing In-hospital Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726164
• Other study ID #: 05/0138
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: December 2014

Study information

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

Clinical Trial Summary

This study investigates the cardioprotective effect of remote ischaemic pre-/postconditioning in patients presenting with a NSTEMI/Unstable angina undergoing PCI.

Description:

Patients presenting with Non ST elevation acute coronary syndromes (NSTEACS) - NSTEMI and Unstable angina patients are enrolled in this study.

Eligible patients are approached, with patient information sheets and are consented for involvement into the study. Patients are randomised to intervention or control. Patients randomised to intervention will receive 3 x 5 minutes of forearm ischaemia (with the cuff inflated to 200 mmHg) separated by 5 minutes of reperfusion between each cuff inflation, prior coronary angiography.

This protocol of episodic forearm ischaemia/reperfusion has been demonstrated to confer remote ischaemic preconditioning-induced protection.

Prior to the intervention, a blood sample will be taken to measure serum troponin T and CK-MB (baseline level). Following PCI patients will be reviewed on the wards and their ongoing recovery will be assessed and reviewed prior to discharge from the study. Troponin T and CK-MB levels will be measured for the 24 hours after PCI, at various time points (6 hour, 12 hour, 24 hour) as a measure of the degree of myocardial damage, and levels compared between the different treatment groups.

Primary end point

Myocardial injury (Peri-procedural Myocardial Infarction and Injury) measured by cTnT and CK-MB release over 24 hours after primary PCI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 626
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients admitted with NSTEMI/ Unstable angina undergoing percutaneous intervention

Exclusion Criteria:

• Known renal failure

• Known liver disease

• Peripheral vascular disease involving upper limbs

• Inability to consent

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Post Procedural Myocardial Infarction

Intervention

Device:
• Remote Conditioning
A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times.
• Sham protocol
An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	Surrey and Sussex Healthcare NHS Trust, University College London Hospitals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-Procedural Myocardial Injury	Peri-Procedural Myocardial Injury will be assessed by the number of patients with peak troponin-T>3x 99th percentile upper reference limit	24 hours post PCI