Coronary Artery DiseaseRECONDNCT02021760
Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction
A study testing Primary Percutaneous Coronary Intervention in people with Coronary Artery Disease and Myocardial Infarction, run by John Pernow at 3 sites in Sweden.
Trial summary
Trial objective: To test the hypothesis that remote per-postconditioning in connection with primary PCI will reduce myocardial infarct size patients with STEMI. Trial Design: Placebo controlled randomized study with parallel groups Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction
- What is being tested?
- Primary Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesSweden
- Study dates
- May 2013to Nov 2015
- 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
- Patient planned for primary PCI.
- Chest pain indicating myocardial ischemia with a duration >30 minutes and < 6 hours prior to randomization.
- ST elevations >0.1 mV (>0.2 mV in V2-V3) in > two contiguous leads in V1-V6.
- Informed consent.
Who cannot join
- Previous myocardial infarction based on medical history or Q-wave on ECG in other area
- Left Bundle Branch Block on ECG.
- Previous CABG
- Cardiac arrest
- Any contraindication for CMR.
- Clinical symptoms of claudication
- Treatment with glibenclamide or cyclosporine on admission.
- Any condition that may interfere with the possibility for the patient to comply with or complete the study protocol.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Karolinska University Hospital
Stockholm, S-17176
Danderyds Hospital
Stockholm
Södersjukhuset
Stockholm
About this study
Official title: Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction in Stockholm (RECOND)
- Trial objective: To test the hypothesis that remote per-postconditioning in connection with primary PCI will reduce myocardial infarct size patients with STEMI.
- Trial Design: Placebo controlled randomized study with parallel groups
- Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance (CMR) day 4-7
- Efficacy Parameters: Myocardial infarct size expressed as a percentage to the myocardium at risk determined by CMR at 6 months.
- Global left ventricular function determined by left ventricular ejection fraction determined by CMR.
- Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day 180.
- Safety Parameters: Major adverse cardiovascular events.
Read the detailed description
See above. 3 patients left to include.
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Being tested
- Primary Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Percutaneous Coronary InterventionProcedure or surgery
Primary Percutanous Coronary Intervention is performed in both Groups.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic per-postconditioning | Active comparator | Remote conditioning is induced by inflation of a blood pressure cuff around the left thigh to 200 mmHg or 20 mmHg above systolic blood pressure (if >180 mmHg) for 5 min followed by deflation for 5 min. At least one of these conditioning cycles is performed before PCI is initiated. If time allows, cycles of remote conditioning (5 min leg ischemia and 5 min reperfusion) are repeated until PCI is performed. Following reperfusion, defined as first balloon inflation, four additional cycles of remote conditioning will be performed. Receives: Procedure: Primary Percutaneous Coronary Intervention |
| Sham | Sham comparator | The sham procedures include application of the cuff around the thigh but it is not inflated.
Otheriwize normal primary PCI. Receives: Procedure: Primary Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance
Measured: 4-7 days following index event
Secondary outcomes (1)
Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance
Measured: 6 months following index event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Pernow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Pernow, Karolinska Institutet
- Investigators
- John Pernow, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021760
- Sponsor's protocol ID
- RECOND
- Acronym
- RECOND
- Status last verified
- Feb 2016
- First submitted
- 20 Dec 2013
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction in Stockholm (RECOND)
- ClinicalTrials.gov ID
- NCT02021760
- Acronym / sponsor ID
- RECOND / RECOND
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- John PernowUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Dec 2013 (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.
- Trial objective: To test the hypothesis that remote per-postconditioning in connection with primary PCI will reduce myocardial infarct size patients with STEMI.
- Trial Design: Placebo controlled randomized study with parallel groups
- Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance (CMR) day 4-7
- Efficacy Parameters: Myocardial infarct size expressed as a percentage to the myocardium at risk determined by CMR at 6 months.
- Global left ventricular function determined by left ventricular ejection fraction determined by CMR.
- Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day 180.
- Safety Parameters: Major adverse cardiovascular events.
Detailed description
See above. 3 patients left to include.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic per-postconditioning | Active comparator | Procedure: Primary Percutaneous Coronary InterventionRemote conditioning is induced by inflation of a blood pressure cuff around the left thigh to 200 mmHg or 20 mmHg above systolic blood pressure (if >180 mmHg) for 5 min followed by deflation for 5 min. At least one of these conditioning cycles is performed before PCI is initiated. If time allows, cycles of remote conditioning (5 min leg ischemia and 5 min reperfusion) are repeated until PCI is performed. Following reperfusion, defined as first balloon inflation, four additional cycles of remote conditioning will be performed. |
| Sham | Sham comparator | Procedure: Primary Percutaneous Coronary InterventionThe sham procedures include application of the cuff around the thigh but it is not inflated. Otheriwize normal primary PCI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient planned for primary PCI.
- Chest pain indicating myocardial ischemia with a duration >30 minutes and < 6 hours prior to randomization.
- ST elevations >0.1 mV (>0.2 mV in V2-V3) in > two contiguous leads in V1-V6.
- Informed consent.
Key exclusion criteria (8 listed)
- Previous myocardial infarction based on medical history or Q-wave on ECG in other area
- Left Bundle Branch Block on ECG.
- Previous CABG
- Cardiac arrest
- Any contraindication for CMR.
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 |
|---|---|---|
| Primary Percutaneous Coronary InterventionPrimary Percutanous Coronary Intervention is performed in both Groups. | Procedure or surgery | Remote Ischemic per-postconditioning, Sham |
Primary outcome
Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance
Time frame: 4-7 days following index event
1 secondary outcome
Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance
Time frame: 6 months following index event
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 Feb 2016.
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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.
John Pernow, Professor principal investigator
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Percutaneous Coronary Intervention in people with Coronary Artery Disease and Myocardial Infarction, run by John Pernow at 3 sites in Sweden.
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 4 inclusion and 8 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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 expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance (time frame: 4-7 days following index event). 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 Feb 2016.