STEMIRemCon-STEMINCT03930589
Remote Ischemic Conditioning in STEMI to Decrease Infarct Size
A study testing Remote Ischemic conditioning in people with STEMI and CAD, run by University of Alberta.
Trial summary
Following acute STEMI patients may have significant myocardial damage and subsequent heart failure. There is currently conflicting data regarding the benefit of remote ischemic conditioning to decrease the magnitude of infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Remote Ischemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- No sites listed yet
- Study dates
- 8 Nov 2013to 26 Nov 2018
- 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
- Patients presenting with STEMI within 6 hours of symptom onset and:
- Are expected to receive reperfusion therapy with either fibrinolysis or primary PCI.
- Documented informed consent (verbal)
Who cannot join
- Cardiogenic shock
- History of anatomical deformity or vascular complication that limit ability to conduct remote ischemic preconditioning
About this study
Official title: A Multi-center Randomized Trial of Remote Ischemic Conditioning to Reduce Infarct Size in Patients With an ST-Elevation Myocardial Infarction
Following acute STEMI patients may have significant myocardial damage and subsequent heart failure. There is currently conflicting data regarding the benefit of remote ischemic conditioning to decrease the magnitude of infarction. Remote ischemic condition is a process where by repetitive intermittent limb ischemia is used to decrease the magnitude of myocardial damage caused by coronary artery occlusion and the subsequent reperfusion injury in STEMI patients. RemCon-STEMI is a multicenter randomized trial to test the impact of remote ischemic conditioning in acute STEMI.
- Being tested
- Remote Ischemic conditioning, Standard of care
- 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 conditioningProcedure or surgery
BP cuff inflation for 5 min and deflation for 5 mins with 4 cycles
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Placebo comparator | no intervention will occur in the standard of care arm Receives: Other: Standard of care |
| Remote Ischemic Conditioning | Active comparator | Remote ischemic conditioning using BP cuff on left arm Receives: Procedure: Remote Ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all cause death
all cause death, cardiogenic shock or chf through 90 days
Measured: 90 days
Secondary outcomes (4)
long term survival
survival
Measured: up to 1 year
myocardial infarction size
mi size using peak elevation of cardiac biomarkers
Measured: within 72 hours of hospital admission
ECG infarct size
QRS score on baseline and discharge ECGS
Measured: with 10 days or hospital discharge whichever occurs first
Reperfusion
ST segment resolution 30 minutes post PCI
Measured: within 24 hours of admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start8 Nov 2013
- Primary completion31 Aug 2017
- Study completion26 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- 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
- Model description
- Remote ischemic condition versus standard of care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian VIGOUR Centre
- Responsible party
- Principal investigator, Robert Welsh, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930589
- Sponsor's protocol ID
- V1 November 15, 2013
- Acronym
- RemCon-STEMI
- Status last verified
- Apr 2019
- First submitted
- 30 Apr 2018
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bainey KR, Zheng Y, Coulden R, Sonnex E, Thompson R, Mei J, Bastiany A, Welsh R. Remote ischaemic conditioning in ST elevation myocardial infarction: a registry-based randomised trial. Heart. 2022 May;108(9):703-709. doi: 10.1136/heartjnl-2021-319455. Epub 2021 Aug 20.
PubMed 34417205
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Trial of Remote Ischemic Conditioning to Reduce Infarct Size in Patients With an ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03930589
- Acronym / sponsor ID
- RemCon-STEMI / V1 November 15, 2013
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian VIGOUR Centre
- Study start
- 8 Nov 2013 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 29 Apr 2019 (actual)
- 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.
Following acute STEMI patients may have significant myocardial damage and subsequent heart failure. There is currently conflicting data regarding the benefit of remote ischemic conditioning to decrease the magnitude of infarction. Remote ischemic condition is a process where by repetitive intermittent limb ischemia is used to decrease the magnitude of myocardial damage caused by coronary artery occlusion and the subsequent reperfusion injury in STEMI patients. RemCon-STEMI is a multicenter randomized trial to test the impact of remote ischemic conditioning in acute STEMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Remote ischemic condition versus standard of care
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Placebo comparator | Other: Standard of careno intervention will occur in the standard of care arm |
| Remote Ischemic Conditioning | Active comparator | Procedure: Remote Ischemic conditioningRemote ischemic conditioning using BP cuff on left arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are expected to receive reperfusion therapy with either fibrinolysis or primary PCI.
- Documented informed consent (verbal)
Key exclusion criteria (2 listed)
- Cardiogenic shock
- History of anatomical deformity or vascular complication that limit ability to conduct remote ischemic preconditioning
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 conditioningBP cuff inflation for 5 min and deflation for 5 mins with 4 cycles | Procedure or surgery | Remote Ischemic Conditioning |
| Standard of careStandard of care | Other | Standard of care |
Primary outcome
Composite of all cause death
Time frame: 90 days
all cause death, cardiogenic shock or chf through 90 days
4 secondary outcomes
long term survival
Time frame: up to 1 year
myocardial infarction size
Time frame: within 72 hours of hospital admission
ECG infarct size
Time frame: with 10 days or hospital discharge whichever occurs first
Reperfusion
Time frame: within 24 hours of admission to hospital
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 29 Apr 2019.
- Derived from this study: PubMed 34417205Bainey KR, Zheng Y, Coulden R, Sonnex E, Thompson R, Mei J, Bastiany A, Welsh R. Remote ischaemic conditioning in ST elevation myocardial infarction: a registry-based randomised trial. Heart. 2022 May;108(9):703-709. doi: 10.1136/heartjnl-2021-319455. Epub 2021 Aug 20.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic conditioning in people with STEMI and CAD, run by University of Alberta.
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 2 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 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Composite of all cause death (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03930589, which also lists 1 linked publication.
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 29 Apr 2019.