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

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ClinicalTrials.gov Identifier: NCT03726164
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborators:
University College London Hospitals
Surrey and Sussex Healthcare NHS Trust
Information provided by (Responsible Party):
University College, London

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

Condition or disease Intervention/treatment Phase
Post Procedural Myocardial Infarction Device: Remote Conditioning Device: Sham protocol Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 624 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Active Comparator: Remote Conditioning group
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
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.
Other Name: RIC

Placebo Comparator: Control Group
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
An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
Other Name: Control




Primary Outcome Measures :
  1. Peri-Procedural Myocardial Injury [ Time Frame: 24 hours post PCI ]
    Peri-Procedural Myocardial Injury will be assessed by the 24 hours area under the curve serum Troponin release



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726164


Sponsors and Collaborators
University College, London
University College London Hospitals
Surrey and Sussex Healthcare NHS Trust
Investigators
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Study Director: Derek M Yellon, PhD, FACC University College, London

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03726164     History of Changes
Other Study ID Numbers: 05/0138
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: May 2017
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases