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

ST-segment Elevation Myocardial Infarction Clinical Trial

— OPTIMAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02894138
• Other study ID #: OPTIMAL-01
• Status: Recruiting
• Phase: Phase 3
• Start date: September 2016
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Vastra Gotaland Region
• Contact: Oskar Angerås, MD, PhD
• Phone: +46703134091
• Email: oskar.angeras[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction

Intervention

Drug:
• alteplase

• Placebo

Locations

Country	Name	City	State
Sweden	Department of Cardiology, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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