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

University College London (UCL)

Status: Completed

Conditions: Post Procedural Myocardial Infarction

Treatments: Device: Remote Conditioning; Device: Sham protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03726164

05/0138

Details and patient eligibility

About

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

Full 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.

Enrollment: 626 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

626 participants in 2 patient groups, including a placebo group

Remote Conditioning group

Active Comparator group

Description:

Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure.

Treatment:

Device: Remote Conditioning

Control Group

Placebo Comparator group

Description:

Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group.

Treatment:

Device: Sham protocol