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ST Elevation Myocardial InfarctionPhase 4SOCCERNCT01423929

Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

A Phase 4 study testing Oxygen and Room air in people with ST Elevation Myocardial Infarction, run by Region Skane at 3 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of SOCCER is to evaluate the effects of treatment with supplemental O2 before and during acute balloon angioplasty (PCI) for patients with ST-elevation myocardial infarction (STEMI). Read more about this study

Who is it for?
Any age
Conditions the study is for
ST Elevation Myocardial Infarction
What is being tested?
Oxygen and Room air
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
3 sitesSweden
Study dates
Jan 2012to Feb 2016
Phase
Phase 4
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • STEMI patient transported with ambulance to SUS Lund or Malmö or Helsingborg hospital, and accepted for acute PCI
  • Symptom duration less than 6 hours
  • Normal SaO2 (≥ 94 %) measured with pulse oximeter
  • Informed consent

Who cannot join

  • Previous AMI
  • Inability to make decision to participate; dementia and the like
  • For CMR: Significant claustrophobia, prostheses or other magnetic material inside the body

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites

  • Helsingborg Hospital

    Helsingborg, SE251 87

  • SUS Lund

    Lund, SE22185

  • SUS Malmö

    Malmö, SE20502

Other trials in Sweden

About this study

The aim of SOCCER is to evaluate the effects of treatment with supplemental O2 before and during acute balloon angioplasty (PCI) for patients with ST-elevation myocardial infarction (STEMI). One hundred STEMI patients are randomized in the ambulance to either standard O2 treatment (10 l/min) or no supplemental O2, to be given until the end of the acute PCI. Cardiac magnetic resonance imaging and echocardiography during the hospital stay is used to assess infarct size and myocardial performance. All patients are followed for 6 months. At 6 months, perceived health and NT-proBNP are recorded for all patients, and an additional echocardiography is performed. The primary endpoint is the fraction of myocardium saved with the acute PCI. The secondary endpoints include the pain difference between inclusion time and start of PCI and myocardial performance on echocardiography.

Read the detailed description

Almost all patients with ST elevation myocardial infarction (STEMI) in Sweden undergo acute balloon angioplasty (PCI) to open the occluded coronary artery, and thereby to reduce or abolish the myocardial infarction. Standard treatment in these cases is 10-15 l of supplemental oxygen to reduce the myocardial ischemia and the infarct size. It is, however, unknown whether supplemental O2 is beneficial or detrimental to patients with STEMI undergoing PCI.

This study aims to evaluate the effects of treatment with supplemental O2 in acute PCI for STEMI.

The study is a multicenter single blind parallel group randomized trial. One hundred normoxic STEMI ambulance patients accepted for primary PCI are randomized in the ambulance to either standard O2 treatment (10 l/min) or no supplemental O2, to be given until the end of the acute PCI. All patients undergo cardiac MRI at day 4-6 to determine area at risk, infarct size and myocardial salvage index. Fifty patients undergo an extended echocardiography during the hospital stay to assess infarct size and wall motion score index. All patients are followed for 6 months. At 6 months, perceived health (EQ-5D) and NT-proBNP are recorded for all patients, and an additional echocardiography is performed for the subgroup of 50 patients. The primary endpoint is myocardial salvage index. Secondary endpoints include pain difference between inclusion time and start of PCI and wall motion score index on echocardiography.

Being tested
Oxygen, Room air
Keywords
Oxygen, Myocardial infarction, Ambulance, Percutaneous coronary intervention, Cardiac magnetic resonance imaging
Medical subject headings
ST Elevation Myocardial Infarction, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxygenDrug

    Fitting of Oxymask TM and treatment with 10 L O2/min

  • Room airDevice

    Fitting of Oxymask TM

Study groups in NCT01423929
Study groupRoleWhat they receive
10 L O2/minExperimentalOxygen breathing via Oxymask TM
Receives: Drug: Oxygen
Room airSham comparatorRoom air breathing via Oxymask TM
Receives: Device: Room air

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial salvage index

    Assessed by cardiac magnetic resonance imaging

    Measured: Day 4-6 after the acute PCI

Secondary outcomes (14)

  1. Pain difference

    Visual analog scale

    Measured: At randomization vs at PCI balloon inflation start

  2. Area at risk

    Assessed by cardiac magnetic resonance imaging

    Measured: Day 4-6 after the acute PCI

  3. Infarct size

    Assessed by cardiac magnetic resonance imaging

    Measured: Day 4-6 after the acute PCI

  4. Ejection fraction

    Assessed by cardiac magnetic resonance imaging

    Measured: Day 4-6 after the acute PCI

  5. Microvascular obstruction

    Assessed by cardiac magnetic resonance imaging

    Measured: Day 4-6 after the acute PCI

  6. Doses of opioids (substance and mg) and betablockers (substance and mg)

    Measured: Given before and during the PCI

  7. Blood oxygen saturation change

    Measured by pulse oximeter

    Measured: From inclusion to PCI start

  8. Infarct size

    Measured with area under TnT curve

    Measured: First 24 h after inclusion

  9. ST segment recovery

    As measured on ECG

    Measured: 90 minutes after acute PCI

  10. TIMI flow

    Measured with coronary angiography

    Measured: During acute PCI

  11. Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc)

    Measured: At 6 months

  12. Perceived health

    Measured with EQ-5D

    Measured: At 6 months

  13. Wall motion score index on echocardiography

    Measured on echocardiography

    Measured: Day 2-3 after acute PCI

  14. Change in wall motion score index

    Measured on echocardiography

    Measured: From index hospitalization to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01423929
Sponsor's protocol ID
2011-001452-11
Acronym
SOCCER
Status last verified
Feb 2016
First submitted
25 Aug 2011
Last updated
31 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • Wijesinghe M, Perrin K, Ranchord A, Simmonds M, Weatherall M, Beasley R. Routine use of oxygen in the treatment of myocardial infarction: systematic review. Heart. 2009 Mar;95(3):198-202. doi: 10.1136/hrt.2008.148742. Epub 2008 Aug 15.

    PubMed 18708420

  • Burls A, Cabello JB, Emparanza JI, Bayliss S, Quinn T. Oxygen therapy for acute myocardial infarction: a systematic review and meta-analysis. Emerg Med J. 2011 Nov;28(11):917-23. doi: 10.1136/emj.2010.103564. Epub 2011 Feb 23.

    PubMed 21346260

  • Nicholson C. A systematic review of the effectiveness of oxygen in reducing acute myocardial ischaemia. J Clin Nurs. 2004 Nov;13(8):996-1007. doi: 10.1111/j.1365-2702.2004.00997.x.

    PubMed 15533106

  • Beasley R, Aldington S, Weatherall M, Robinson G, McHaffie D. Oxygen therapy in myocardial infarction: an historical perspective. J R Soc Med. 2007 Mar;100(3):130-3. doi: 10.1177/014107680710000311. No abstract available.

    PubMed 17339308

  • Farquhar H, Weatherall M, Wijesinghe M, Perrin K, Ranchord A, Simmonds M, Beasley R. Systematic review of studies of the effect of hyperoxia on coronary blood flow. Am Heart J. 2009 Sep;158(3):371-7. doi: 10.1016/j.ahj.2009.05.037. Epub 2009 Jul 15.

    PubMed 19699859

  • Mokhtari A, Akbarzadeh M, Sparv D, Bhiladvala P, Arheden H, Erlinge D, Khoshnood A. Oxygen therapy in patients with ST elevation myocardial infarction based on the culprit vessel: results from the randomized controlled SOCCER trial. BMC Emerg Med. 2020 Feb 18;20(1):12. doi: 10.1186/s12873-020-00309-y.

    PubMed 32070283

  • Khoshnood A, Akbarzadeh M, Carlsson M, Sparv D, Bhiladvala P, Mokhtari A, Erlinge D, Ekelund U. Effect of oxygen therapy on chest pain in patients with ST elevation myocardial infarction: results from the randomized SOCCER trial. Scand Cardiovasc J. 2018 Apr;52(2):69-73. doi: 10.1080/14017431.2018.1439183. Epub 2018 Feb 13.

    PubMed 29436868

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxygen and Room air in people with ST Elevation Myocardial Infarction, run by Region Skane 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 3 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 31 Aug 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 salvage index (time frame: Day 4-6 after the acute PCI). 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 NCT01423929, which also lists 7 linked publications.

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 31 Aug 2016.

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