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

Primary Purpose

ST-segment Elevation Myocardial Infarction

Status
Unknown status
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
alteplase
Placebo
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology, Sahlgrenska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Alteplase

Placebo

Observational

Arm Description

40 patients: 4-5 minutes of infusion of 10 ml of alteplase 2mg/ml in culprit vessel

40 patients: 4-5 minutes of infusion of 10 ml of NaCl in culprit vessel

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 24, 2016
Last Updated
September 3, 2021
Sponsor
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT02894138
Brief Title
Optimal Coronary Flow After PCI for Myocardial Infarction - a Pilot Study
Acronym
OPTIMAL
Official Title
Optimal Coronary Flow After PCI for Myocardial Infarction - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alteplase
Arm Type
Experimental
Arm Description
40 patients: 4-5 minutes of infusion of 10 ml of alteplase 2mg/ml in culprit vessel
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
40 patients: 4-5 minutes of infusion of 10 ml of NaCl in culprit vessel
Arm Title
Observational
Arm Type
No Intervention
Arm Description
10 patients with IMR <30 will undergo the same follow-up as the randomised patients
Intervention Type
Drug
Intervention Name(s)
alteplase
Other Intervention Name(s)
Actilyse®
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
NaCl
Primary Outcome Measure Information:
Title
Ratio of myocardial infarct size to area at risk assessed by MRI
Description
MRI performed early (day 2-6) to assess area at risk and late (3 months) to assess infarct size
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change of index of microvascular resistance and coronary flow reserve
Description
Difference in invasively measured IMR and CFR before and after drug administration
Time Frame
Immediately after drug administration during invasive index procedure
Title
Degree of microvascular obstruction assessed by MRI
Description
Degree of microvascular obstruction assessed by MRI
Time Frame
2-6 days
Title
Peak level of Troponin T
Description
Peak level of Troponin T
Time Frame
12 hours
Title
Level of NtProBNP
Description
Level of NtProBNP
Time Frame
12 hours
Title
Non invasive CFR
Description
CFR measured with transthoracic echo doppler
Time Frame
3 months
Title
Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)
Description
Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)
Time Frame
3 months
Title
Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)
Description
Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)
Time Frame
12 months
Title
Re-hospitalisation for heart failure
Description
Re-hospitalisation for heart failure
Time Frame
12 months
Title
Re-hospitalisation for myocardial infarction
Description
Re-hospitalisation for myocardial infarction
Time Frame
12 months
Title
Cardiovascular death
Description
Cardiovascular death
Time Frame
12 months
Title
Bleeding according to BARC-criteria
Description
Bleeding events during or after index PCI during index hospitalisation
Time Frame
7 days
Title
Myocardial hemorrhage at MRI
Description
Myocardial hemorrhage at MRI
Time Frame
2-6 days
Title
Change in hemoglobin
Description
Change in hemoglobin
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria for randomization: 1. IMR measured in culprit vessel > 30 Criteria for IMR measurement: Inclusion Criteria: 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 Exclusion Criteria: 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oskar Angerås, MD, PhD
Phone
+46703134091
Email
oskar.angeras@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oskar Angerås, MD, PhD
Organizational Affiliation
Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oskar Angerås, MD, PhD
Phone
+46703134091
Email
oskar.angeras@vgregion.se

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18237685
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.
Results Reference
background
PubMed Identifier
19684025
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.
Results Reference
background
PubMed Identifier
23681066
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.
Results Reference
background
PubMed Identifier
24637066
Citation
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.
Results Reference
background
PubMed Identifier
21670242
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. No abstract available.
Results Reference
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Optimal Coronary Flow After PCI for Myocardial Infarction - a Pilot Study

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