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ST-segment Elevation Myocardial InfarctionPhase 3OPTIMALNCT02894138

Optimal Coronary Flow After PCI for Myocardial Infarction - a Pilot Study

A Phase 3 study testing alteplase in people with ST-segment Elevation Myocardial Infarction, run by Vastra Gotaland Region at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study the investigators test the hypothesis that alteplase given intra coronary after PCI reduce infarct size in patients with ST-elevation myocardial infarction(STEMI) and impaired microvascular function defined as a value of index of microvascular resistance (IMR) >30. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
alteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteSweden
Study dates
Sep 2016to Dec 2022
Phase
Phase 3
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Oral and signed informed consent
  • Males and females 18 - 85 years of age
  • Diagnosis of ST-elevation myocardial infarction (STEMI) including occlusion of culprit vessel on angiography
  • Onset of continuous symptoms within 12 hours
  • Have undergone PCI of culprit vessel
  • Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent

Who cannot join

  • Previously known ejection fraction <30%
  • Previous PCI in the culprit vessel
  • Chronic total occlusion in major vessel
  • Any history of bleeding diathesis, known coagulopathy, or will refuse blood transfusions
  • Recent history or known platelet count <100.000 cells/mm3 or Hbg < 10 g/dL
  • Known reduced kidney function with estimated glomerular filtration rate (GFR) <30 ml/min/1.73m2.
Show all 19Show fewer
  • Previous hemorrhagic stroke
  • Ongoing oral anticoagulation treatment
  • Severe asthma requiring daily treatment
  • Any mechanical complication (e.g. ventricular septal defect, papillary muscle rupture, cardiac tamponade)
  • Atrioventricular block grade III
  • Known inability to undergo MRI investigation
  • Permanent pacemaker
  • Pronounced claustrophobia
  • Known intolerance to study drug
  • Known intolerance to adenosine
  • Pregnancy
  • Participation in another investigational drug study
  • Previous randomization in the OPTIMAL-PCI trial

Trial locations and contacts

1 site in 1 country.

Oskar Angerås, MD, PhD contact

+46703134091

oskar.angeras@vgregion.se

Sweden1 site, 1 recruiting

  • Department of Cardiology, Sahlgrenska University Hospital

    Gothenburg

    Oskar Angerås, MD, PhD, +46703134091, oskar.angeras@vgregion.se

    Recruiting

Other trials in Sweden

About this study

In this study the investigators test the hypothesis that alteplase given intra coronary after PCI reduce infarct size in patients with ST-elevation myocardial infarction(STEMI) and impaired microvascular function defined as a value of index of microvascular resistance (IMR) >30.

Read the detailed description

After coronary stenting, index of microvascular resistance (IMR) will be measured invasively. Patients with IMR >30 will be randomised to 20 mg alteplase or placebo (NaCl) administered in the culprit vessel through a microcatheter. Magnet resonance imaging (MRI) of the myocardium will be performed early (2-6 days) and late (3 months) to estimate the primary endpoint (infarct size).

10 non-randomised patients, with IMR <30, will undergo the same follow-up as the randomised patients.

Clinical events for all randomised and non-randomised patients will be collected from Swedish national registries and by telephone at 3 and 12 months.

Being tested
alteplase, Placebo
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.

  • alteplaseDrug

    Also called Actilyse®

  • PlaceboDrug

    Also called NaCl

Study groups in NCT02894138
Study groupRoleWhat they receive
AlteplaseExperimental40 patients: 4-5 minutes of infusion of 10 ml of alteplase 2mg/ml in culprit vessel
Receives: Drug: alteplase
PlaceboPlacebo comparator40 patients: 4-5 minutes of infusion of 10 ml of NaCl in culprit vessel
Receives: Drug: Placebo
ObservationalNo intervention10 patients with IMR <30 will undergo the same follow-up as the randomised patients

What is being measured

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

  1. Ratio of myocardial infarct size to area at risk assessed by MRI

    MRI performed early (day 2-6) to assess area at risk and late (3 months) to assess infarct size

    Measured: 3 months

Secondary outcomes (13)

  1. Change of index of microvascular resistance and coronary flow reserve

    Difference in invasively measured IMR and CFR before and after drug administration

    Measured: Immediately after drug administration during invasive index procedure

  2. Degree of microvascular obstruction assessed by MRI

    Degree of microvascular obstruction assessed by MRI

    Measured: 2-6 days

  3. Peak level of Troponin T

    Peak level of Troponin T

    Measured: 12 hours

  4. Level of NtProBNP

    Level of NtProBNP

    Measured: 12 hours

  5. Non invasive CFR

    CFR measured with transthoracic echo doppler

    Measured: 3 months

  6. Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)

    Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)

    Measured: 3 months

  7. Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)

    Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)

    Measured: 12 months

  8. Re-hospitalisation for heart failure

    Re-hospitalisation for heart failure

    Measured: 12 months

  9. Re-hospitalisation for myocardial infarction

    Re-hospitalisation for myocardial infarction

    Measured: 12 months

  10. Cardiovascular death

    Cardiovascular death

    Measured: 12 months

  11. Bleeding according to BARC-criteria

    Bleeding events during or after index PCI during index hospitalisation

    Measured: 7 days

  12. Myocardial hemorrhage at MRI

    Myocardial hemorrhage at MRI

    Measured: 2-6 days

  13. Change in hemoglobin

    Change in hemoglobin

    Measured: 12 hours

Timeline

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

  1. First posted9 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2022 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02894138
Sponsor's protocol ID
OPTIMAL-01
Acronym
OPTIMAL
Status last verified
Sep 2021
First submitted
24 Aug 2016
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Fearon WF, Shah M, Ng M, Brinton T, Wilson A, Tremmel JA, Schnittger I, Lee DP, Vagelos RH, Fitzgerald PJ, Yock PG, Yeung AC. Predictive value of the index of microcirculatory resistance in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2008 Feb 5;51(5):560-5. doi: 10.1016/j.jacc.2007.08.062.

    PubMed 18237685

  • Lim HS, Yoon MH, Tahk SJ, Yang HM, Choi BJ, Choi SY, Sheen SS, Hwang GS, Kang SJ, Shin JH. Usefulness of the index of microcirculatory resistance for invasively assessing myocardial viability immediately after primary angioplasty for anterior myocardial infarction. Eur Heart J. 2009 Dec;30(23):2854-60. doi: 10.1093/eurheartj/ehp313. Epub 2009 Aug 14.

    PubMed 19684025

  • Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.

    PubMed 23681066

  • Boscarelli D, Vaquerizo B, Miranda-Guardiola F, Arzamendi D, Tizon H, Sierra G, Delgado G, Fantuzzi A, Estrada D, Garcia-Picart J, Cinca J, Serra A. Intracoronary thrombolysis in patients with ST-segment elevation myocardial infarction presenting with massive intraluminal thrombus and failed aspiration. Eur Heart J Acute Cardiovasc Care. 2014 Sep;3(3):229-36. doi: 10.1177/2048872614527008. Epub 2014 Mar 17.

    PubMed 24637066

  • Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

    PubMed 21670242

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing alteplase in people with ST-segment Elevation Myocardial Infarction, run by Vastra Gotaland Region at 1 site 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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Oskar Angerås, MD, PhD (+46703134091, oskar.angeras@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratio of myocardial infarct size to area at risk assessed by MRI (time frame: 3 months). 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 NCT02894138, which also lists 5 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 5 Sep 2021.

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