Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction (LATE-MI)
Primary Purpose
Ischemic Heart Disease, ST-segment Elevation Myocardial Infarction
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PCI
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Myocardial infarction, Late presenters, Primary percutaneous coronary intervention, Reperfusion, Angioplasty, Duration of ischemia, Cardiovascular magnetic resonance imaging
Eligibility Criteria
Inclusion Criteria:
- Inclusion criteria:
- Patients more than 18 years of age.
- STEMI > 12 hours and < 36 hours.
- Clinical stable, i.e. no on going angina, hemodynamically stable (systolic BP > 90) and Killip class < 3.
Exclusion Criteria:
- Clinical instability which requires an acute invasive strategy.
- Left main occlusion or multivessel disease which requires CABG.
- Previous Q-wave infarction in the current infarct related artery.
- Left Bundle Branch Block (LBBB).
- Severe renal insufficiency.
- Pacemaker
- Chronic atrial fibrillation.
- Previous Coronary Artery Bypass Surgery (CABG).
- Pregnancy.
- Other severe illness with life expectancy less than 1 year
Sites / Locations
- RigshospitaletRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acute PCI
Subacute PCI
Arm Description
Acute re-opening of the occluded coronary artery including premedication as for primary PCI within 12 hours
Standard subacute re-opening of the occluded coronary artery including premedication as for subacute PCI within 72 hours
Outcomes
Primary Outcome Measures
Acute salvage index evaluated by MRI
MRI within 48 timer after index admission will be used to measure are at risk (AAR, T2-weighted) and acute infarct size (IZ). Acute salvage index is (AAR-IZ)/AAR
Secondary Outcome Measures
Final infarct size
Please see above
Final myocardial salvage index
As for primary endpoint but IZ is measured within the index admission
Acute infarct size
Microvascular obstruction (MVO)
Left Ventricular Ejection Fraction (LVEF)
Measured by MRI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02445885
Brief Title
Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
Acronym
LATE-MI
Official Title
Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2039 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Engstrom
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Although recommended therapy for patients with ST-segment elevation myocardial infarction is primary PCI, it remains unestablished whether patients with a symptom duration of more 12 hours benefit from acute revascularisation.
This study aims to investigate whether acute intervention is superior to subacute intervention in these patients.
Detailed Description
The recommended therapy for patients with ST-segment elevation myocardial infarction (STEMI) is to restore normal coronary blood flow with timely reperfusion by percutaneous coronary intervention (PCI), and thereby minimize the extent of cell death and preserving cardiac function. The duration of ischemia and timely PCI are major determinants for the size of the myocardial infarction and prognosis. Thus, acute PCI should be performed within 12 hours after symptom onset. The effect of PCI and timing of PCI are, however, much more uncertain for late presenters who contact the health service > 12 hours from symptom. Thus, it is still unknown whether late presenters should be treated with acute PCI or medical treatment with delayed PCI (24-72 h after first medical contact).
The study investigates the effect on final salvage index evaluated by magnetic resonance imaging of acute PCI of late presenters.
The overall objective of the study is to investigate whether late presenters may benefit from acute PCI, and thus whether to extend the currently recommended time limit of 12 hours for acute PCI in patients with STEMI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, ST-segment Elevation Myocardial Infarction
Keywords
Myocardial infarction, Late presenters, Primary percutaneous coronary intervention, Reperfusion, Angioplasty, Duration of ischemia, Cardiovascular magnetic resonance imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acute PCI
Arm Type
Experimental
Arm Description
Acute re-opening of the occluded coronary artery including premedication as for primary PCI within 12 hours
Arm Title
Subacute PCI
Arm Type
Active Comparator
Arm Description
Standard subacute re-opening of the occluded coronary artery including premedication as for subacute PCI within 72 hours
Intervention Type
Procedure
Intervention Name(s)
PCI
Intervention Description
Guideline directed Percutaneous Coronary Intervention
Primary Outcome Measure Information:
Title
Acute salvage index evaluated by MRI
Description
MRI within 48 timer after index admission will be used to measure are at risk (AAR, T2-weighted) and acute infarct size (IZ). Acute salvage index is (AAR-IZ)/AAR
Time Frame
1-2 days
Secondary Outcome Measure Information:
Title
Final infarct size
Description
Please see above
Time Frame
3 months
Title
Final myocardial salvage index
Description
As for primary endpoint but IZ is measured within the index admission
Time Frame
1-2 days
Title
Acute infarct size
Time Frame
1-2 days
Title
Microvascular obstruction (MVO)
Time Frame
1-2 days
Title
Left Ventricular Ejection Fraction (LVEF)
Description
Measured by MRI
Time Frame
1-2 days and 3 months
Other Pre-specified Outcome Measures:
Title
Left Ventricular (LV) volumes
Time Frame
1-2 days and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria:
Patients more than 18 years of age.
STEMI > 12 hours and < 36 hours.
Clinical stable, i.e. no on going angina, hemodynamically stable (systolic BP > 90) and Killip class < 3.
Exclusion Criteria:
Clinical instability which requires an acute invasive strategy.
Left main occlusion or multivessel disease which requires CABG.
Previous Q-wave infarction in the current infarct related artery.
Left Bundle Branch Block (LBBB).
Severe renal insufficiency.
Pacemaker
Chronic atrial fibrillation.
Previous Coronary Artery Bypass Surgery (CABG).
Pregnancy.
Other severe illness with life expectancy less than 1 year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Nepper-Christensen, MD
Phone
+4535457586
Email
lars.nepper@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Engstrøm, MDSci, PhD
Phone
+4535452017
Email
thomas.engstroem@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Nepper-Christensen, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Capital Region
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Nepper-Christensen, MD
First Name & Middle Initial & Last Name & Degree
Thomas Engstrøm, DSci, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
20716739
Citation
Terkelsen CJ, Sorensen JT, Maeng M, Jensen LO, Tilsted HH, Trautner S, Vach W, Johnsen SP, Thuesen L, Lassen JF. System delay and mortality among patients with STEMI treated with primary percutaneous coronary intervention. JAMA. 2010 Aug 18;304(7):763-71. doi: 10.1001/jama.2010.1139.
Results Reference
background
PubMed Identifier
19442942
Citation
Carlsson M, Ubachs JF, Hedstrom E, Heiberg E, Jovinge S, Arheden H. Myocardium at risk after acute infarction in humans on cardiac magnetic resonance: quantitative assessment during follow-up and validation with single-photon emission computed tomography. JACC Cardiovasc Imaging. 2009 May;2(5):569-76. doi: 10.1016/j.jcmg.2008.11.018.
Results Reference
background
PubMed Identifier
19357105
Citation
Busk M, Kaltoft A, Nielsen SS, Bottcher M, Rehling M, Thuesen L, Botker HE, Lassen JF, Christiansen EH, Krusell LR, Andersen HR, Nielsen TT, Kristensen SD. Infarct size and myocardial salvage after primary angioplasty in patients presenting with symptoms for <12 h vs. 12-72 h. Eur Heart J. 2009 Jun;30(11):1322-30. doi: 10.1093/eurheartj/ehp113. Epub 2009 Apr 8.
Results Reference
result
PubMed Identifier
15956631
Citation
Schomig A, Mehilli J, Antoniucci D, Ndrepepa G, Markwardt C, Di Pede F, Nekolla SG, Schlotterbeck K, Schuhlen H, Pache J, Seyfarth M, Martinoff S, Benzer W, Schmitt C, Dirschinger J, Schwaiger M, Kastrati A; Beyond 12 hours Reperfusion AlternatiVe Evaluation (BRAVE-2) Trial Investigators. Mechanical reperfusion in patients with acute myocardial infarction presenting more than 12 hours from symptom onset: a randomized controlled trial. JAMA. 2005 Jun 15;293(23):2865-72. doi: 10.1001/jama.293.23.2865.
Results Reference
result
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Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
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