NCT03726164

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
626

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2017

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 1, 2020

Completed
Last Updated

December 1, 2020

Status Verified

May 1, 2017

Enrollment Period

6.5 years

First QC Date

May 8, 2017

Results QC Date

November 4, 2020

Last Update Submit

November 4, 2020

Conditions

Post Procedural Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Remote Conditioning group

ACTIVE COMPARATOR

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.

Device: Remote Conditioning

Control Group

PLACEBO COMPARATOR

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.

Device: Sham protocol

Interventions

Remote ConditioningDEVICE

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.

Also known as: RIC
Remote Conditioning group
Sham protocolDEVICE

An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.

Also known as: Control
Control Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted with NSTEMI/ Unstable angina undergoing percutaneous intervention

You may not qualify if:

  • Known renal failure
  • Known liver disease
  • Peripheral vascular disease involving upper limbs
  • Inability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Prof Derek Hausenloy
Organization
University College London
d.hausenloy@ucl.ac.uk
+6584053767

Study Officials

  • Derek M Yellon, PhD, FACC

    University College, London

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

October 31, 2018

Study Start

June 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 1, 2020

Results First Posted

December 1, 2020

Record last verified: 2017-05