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

September 3, 2021 updated by: Vastra Gotaland Region
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Recruiting
        • Department of Cardiology, Sahlgrenska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Criteria for randomization:

1. IMR measured in culprit vessel > 30

Criteria for IMR measurement:

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previously known ejection fraction <30%
  2. Previous PCI in the culprit vessel
  3. Chronic total occlusion in major vessel
  4. Any history of bleeding diathesis, known coagulopathy, or will refuse blood transfusions
  5. Recent history or known platelet count <100.000 cells/mm3 or Hbg < 10 g/dL
  6. Known reduced kidney function with estimated glomerular filtration rate (GFR) <30 ml/min/1.73m2.
  7. Previous hemorrhagic stroke
  8. Ongoing oral anticoagulation treatment
  9. Severe asthma requiring daily treatment
  10. Any mechanical complication (e.g. ventricular septal defect, papillary muscle rupture, cardiac tamponade)
  11. Atrioventricular block grade III

  12. Known inability to undergo MRI investigation

    Permanent pacemaker

    • Pronounced claustrophobia
  13. Known intolerance to study drug
  14. Known intolerance to adenosine
  15. Pregnancy
  16. Participation in another investigational drug study
  17. Previous randomization in the OPTIMAL-PCI trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alteplase
40 patients: 4-5 minutes of infusion of 10 ml of alteplase 2mg/ml in culprit vessel
Drug: alteplase
Other Names:
  • Actilyse®
Placebo Comparator: Placebo
40 patients: 4-5 minutes of infusion of 10 ml of NaCl in culprit vessel
Drug: Placebo
Other Names:
  • NaCl
No Intervention: Observational
10 patients with IMR <30 will undergo the same follow-up as the randomised patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of myocardial infarct size to area at risk assessed by MRI
Time Frame: 3 months
MRI performed early (day 2-6) to assess area at risk and late (3 months) to assess infarct size
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of index of microvascular resistance and coronary flow reserve
Time Frame: Immediately after drug administration during invasive index procedure
Difference in invasively measured IMR and CFR before and after drug administration
Immediately after drug administration during invasive index procedure
Degree of microvascular obstruction assessed by MRI
Time Frame: 2-6 days
Degree of microvascular obstruction assessed by MRI
2-6 days
Peak level of Troponin T
Time Frame: 12 hours
Peak level of Troponin T
12 hours
Level of NtProBNP
Time Frame: 12 hours
Level of NtProBNP
12 hours
Non invasive CFR
Time Frame: 3 months
CFR measured with transthoracic echo doppler
3 months
Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)
Time Frame: 3 months
Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)
3 months
Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)
Time Frame: 12 months
Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)
12 months
Re-hospitalisation for heart failure
Time Frame: 12 months
Re-hospitalisation for heart failure
12 months
Re-hospitalisation for myocardial infarction
Time Frame: 12 months
Re-hospitalisation for myocardial infarction
12 months
Cardiovascular death
Time Frame: 12 months
Cardiovascular death
12 months
Bleeding according to BARC-criteria
Time Frame: 7 days
Bleeding events during or after index PCI during index hospitalisation
7 days
Myocardial hemorrhage at MRI
Time Frame: 2-6 days
Myocardial hemorrhage at MRI
2-6 days
Change in hemoglobin
Time Frame: 12 hours
Change in hemoglobin
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: Oskar Angerås, MD, PhD, Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTIMAL-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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