ST-segment Elevation Myocardial Infarction (STEMI)ERIC-LYSISNCT02197117
Effect of Remote Ischemic Conditioning in Heart Attack Patients
A study testing Remote ischemic conditioning in people with ST-segment Elevation Myocardial Infarction (STEMI), run by University College, London at 5 sites in Mauritius.
Trial summary
New treatments are required to improve health outcomes in patients with ischemic heart disease. This is especially so in developing countries such as Mauritius in which optimal therapy for acute myocardial infarction may not be widely available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 519 participants
- Where
- 5 sitesMauritius
- Study dates
- Mar 2011to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Presentation within 12 hours of onset of chest pain
- ECG showing ST-segment elevation of ≥0.1mV in two contiguous leads (≥0.2mV in leads V1-V3)
Who cannot join
- -None -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Mauritius5 sites
Victoria Hospital
Candos
Flacq Hospital
Centre de Flacq
Sir Seewoosagur Ramgoolam National Hospital
Pamplemousses
Dr AG Jeetoo Hospital
Port Louis
Jawaharlal Nehru Hospital
Rose Belle
About this study
Official title: Effect of Remote Ischaemic Conditioning in STEMI Patients Treated by thromboLYSIS: A Randomised Controlled Clinical Trial (the ERIC-LYSIS Study)
New treatments are required to improve health outcomes in patients with ischemic heart disease. This is especially so in developing countries such as Mauritius in which optimal therapy for acute myocardial infarction may not be widely available. For example for patients presenting with a heart attack (caused by a blockage in one of the heart blood vessels) the treatment of choice would be to remove the blockage by primary percutaneous coronary intervention (PCI) using an angioplasty balloon and put a stent (a spring-like structure) to keep the artery opened. However, PCI is not widely available in Mauritius and heart attack patients are given clot-busting therapy to remove the blockage, but this is not as effective as PCI.
Therefore, in this research study we investigate a new cheap treatment that may help protect the heart against damage during a heart attack, called remote ischemic conditioning (RIC), in which a blood pressure cuff is placed on the upper arm and inflated for 5 minute and deflated for 5 minutes a cycle which is repeated 4 times in total in patients presenting with a heart attack. By temporarily depriving oxygen and nutrients to the arm with the blood pressure cuff a protective signal can be relayed to the heart to reduce the amount of damage occurring during the heart attack and thereby prevent the onset of heart failure.
Study hypothesis: Remote ischaemic conditioning will reduce the amount of damage occurring to the heart muscle during a heart attack..
- Being tested
- Remote ischemic conditioning, Control
- Keywords
- ST-segment elevation myocardial infarction (STEMI); thrombolysis, remote ischemic conditioning, myocardial infarct size, cardioprotection
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningDevice
ControlDevice
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic conditioning | Active comparator | Standard blood pressure cuff placed on upper arm and inflated to 200 mmHg. The cuff is left inflated at this level for 5 minutes and then rapidly deflated to 0 mmHg left deflated for 5 minutes0 this cycle is repeated 4 times in total. Receives: Device: Remote ischemic conditioning |
| Control | Sham comparator | Standard blood pressure cuff placed on upper arm and left un-inflated for 40 minutes, and then cuff is removed. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarct size
Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis.
Measured: Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis
Secondary outcomes (1)
Acute kidney injury
Measured by serum creatinine at 24 hours.
Measured: Measured by serum creatinine at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startMar 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies 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
- 519 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Hausenloy, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197117
- Sponsor's protocol ID
- ERIC-LYSIS
- Acronym
- ERIC-LYSIS
- Status last verified
- May 2017
- First submitted
- 18 Jul 2014
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischaemic Conditioning in STEMI Patients Treated by thromboLYSIS: A Randomised Controlled Clinical Trial (the ERIC-LYSIS Study)
- ClinicalTrials.gov ID
- NCT02197117
- Acronym / sponsor ID
- ERIC-LYSIS / ERIC-LYSIS
- Keywords
- ST-segment elevation myocardial infarction (STEMI); thrombolysis, remote ischemic conditioning, myocardial infarct size, cardioprotection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 519 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
New treatments are required to improve health outcomes in patients with ischemic heart disease. This is especially so in developing countries such as Mauritius in which optimal therapy for acute myocardial infarction may not be widely available. For example for patients presenting with a heart attack (caused by a blockage in one of the heart blood vessels) the treatment of choice would be to remove the blockage by primary percutaneous coronary intervention (PCI) using an angioplasty balloon and put a stent (a spring-like structure) to keep the artery opened. However, PCI is not widely available in Mauritius and heart attack patients are given clot-busting therapy to remove the blockage, but this is not as effective as PCI.
Therefore, in this research study we investigate a new cheap treatment that may help protect the heart against damage during a heart attack, called remote ischemic conditioning (RIC), in which a blood pressure cuff is placed on the upper arm and inflated for 5 minute and deflated for 5 minutes a cycle which is repeated 4 times in total in patients presenting with a heart attack. By temporarily depriving oxygen and nutrients to the arm with the blood pressure cuff a protective signal can be relayed to the heart to reduce the amount of damage occurring during the heart attack and thereby prevent the onset of heart failure.
Study hypothesis: Remote ischaemic conditioning will reduce the amount of damage occurring to the heart muscle during a heart attack..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic conditioning | Active comparator | Device: Remote ischemic conditioningStandard blood pressure cuff placed on upper arm and inflated to 200 mmHg. The cuff is left inflated at this level for 5 minutes and then rapidly deflated to 0 mmHg left deflated for 5 minutes0 this cycle is repeated 4 times in total. |
| Control | Sham comparator | Device: ControlStandard blood pressure cuff placed on upper arm and left un-inflated for 40 minutes, and then cuff is removed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Presentation within 12 hours of onset of chest pain
- ECG showing ST-segment elevation of ≥0.1mV in two contiguous leads (≥0.2mV in leads V1-V3)
Key exclusion criteria (1 listed)
- -None -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioning | Device | Remote ischemic conditioning |
| Control | Device | Control |
Primary outcome
Myocardial infarct size
Time frame: Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis
Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis.
1 secondary outcome
Acute kidney injury
Time frame: Measured by serum creatinine at 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with ST-segment Elevation Myocardial Infarction (STEMI), run by University College, London at 5 sites in Mauritius.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Mauritius. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infarct size (time frame: Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.