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Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction (LATE-MI)

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ClinicalTrials.gov Identifier: NCT02445885
Recruitment Status : Recruiting
First Posted : May 15, 2015
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Engstrom, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
Ischemic Heart Disease ST-segment Elevation Myocardial Infarction Procedure: PCI Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
Study Start Date : May 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Acute PCI
Acute re-opening of the occluded coronary artery including premedication as for primary PCI within 12 hours
Procedure: PCI
Guideline directed Percutaneous Coronary Intervention

Active Comparator: Subacute PCI
Standard subacute re-opening of the occluded coronary artery including premedication as for subacute PCI within 72 hours
Procedure: PCI
Guideline directed Percutaneous Coronary Intervention




Primary Outcome Measures :
  1. Final salvage index evaluated by MRI [ Time Frame: 3 months ]
    MRI within 48 timer after index admission will be used to measure are at risk (AAR, T2-weighted) whereas final infarct size (IZ) will be measured be means of gadolinium after 3 months. Final salvage index is (AAR-IZ)/AAR


Secondary Outcome Measures :
  1. Final infarct size [ Time Frame: 3 months ]
    Please see above

  2. Acute myocardial salvage index [ Time Frame: <48 hours ]
    As for primary endpoint but IZ is measured within the index admission

  3. Acute infarct size [ Time Frame: <48 hours ]
  4. Microvascular obstruction (MVO) [ Time Frame: Within index admission ]
  5. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: Index admission and 3 months ]
    Measured by MRI


Other Outcome Measures:
  1. Left Ventricular (LV) volumes [ Time Frame: Index admission and 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445885


Contacts
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Contact: Lars Nepper-Christensen, MD +4535457586 lars.nepper@gmail.com
Contact: Thomas Engstrøm, MDSci, PhD +4535452017 thomas.engstroem@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Capital Region, Denmark, 2100
Contact: Lars Nepper-Christensen, MD         
Contact: Thomas Engstrøm, DSci, PhD         
Sponsors and Collaborators
Thomas Engstrom
Investigators
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Principal Investigator: Lars Nepper-Christensen, MD Rigshospitalet, Denmark

Publications of Results:
Other Publications:
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Responsible Party: Thomas Engstrom, Chief Consultant, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02445885     History of Changes
Other Study ID Numbers: LATE-MI
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Keywords provided by Thomas Engstrom, Rigshospitalet, Denmark:
Myocardial infarction
Late presenters
Primary percutaneous coronary intervention
Reperfusion
Angioplasty
Duration of ischemia
Cardiovascular magnetic resonance imaging

Additional relevant MeSH terms:
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Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Coronary Artery Disease
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases