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

Phase 3

• Conditions: ST-segment Elevation Myocardial Infarction
• Interventions: Drug: alteplase; Drug: Placebo

• Registration Number: NCT02894138
• Lead Sponsor: Vastra Gotaland Region

Brief 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.

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 Timeline

• Study First Submitted: 2016-08-24
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-02
• Study First Posted: 2016-09-09
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-05
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alteplase	alteplase	40 patients: 4-5 minutes of infusion of 10 ml of alteplase 2mg/ml in culprit vessel
Placebo	Placebo	40 patients: 4-5 minutes of infusion of 10 ml of NaCl in culprit vessel

Primary Outcome Measures

Name	Time	Method
Ratio of myocardial infarct size to area at risk assessed by MRI	3 months	MRI performed early (day 2-6) to assess area at risk and late (3 months) to assess infarct size

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Cardiology, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden