Post Procedural Myocardial InfarctionNCT03726164
Remote Ischaemic Postconditioning in the Clinical Setting of NSTEACS and Urgent PCI
A study testing Remote Conditioning in people with Post Procedural Myocardial Infarction, run by University College, London.
Trial summary
This study investigates the cardioprotective effect of remote ischaemic pre-/postconditioning in patients presenting with a NSTEMI/Unstable angina undergoing PCI. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Post Procedural Myocardial Infarction
- What is being tested?
- Remote Conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 626 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Dec 2014
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted with NSTEMI/ Unstable angina undergoing percutaneous intervention
Who cannot join
- Known renal failure
- Known liver disease
- Peripheral vascular disease involving upper limbs
- Inability to consent
About this study
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
This study investigates the cardioprotective effect of remote ischaemic pre-/postconditioning in patients presenting with a NSTEMI/Unstable angina undergoing PCI.
Read the 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.
- Conditions
- Post Procedural Myocardial Infarction
- Being tested
- Remote Conditioning, Sham protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ConditioningDevice
Also called RIC
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 protocolDevice
Also called Control
An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours post PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study startJun 2008
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Procedural Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals, Surrey and Sussex Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Derek M Yellon, PhD, FACC, Study director, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726164
- Sponsor's protocol ID
- 05/0138
- Status last verified
- May 2017
- First submitted
- 8 May 2017
- Last updated
- 1 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes