DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction

Not Applicable

Active, not recruiting

• Conditions: ST Segment Elevation Myocardial Infarction
• Interventions: Other: Deferred stenting in primary PCI.; Other: Conventional primary PCI; Other: Ischemic postconditioning.

• Registration Number: NCT01435408
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

This study focuses on Cardioprotective strategies.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-16
• Primary Completion: 2016-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Age ≥ 18 years.
• Acute onset of chest pain of < 12 hours' duration.
• ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.

Culprit lesion in a major native vessel.

Exclusion Criteria

• Pregnancy.
• Known intolerance of ASA, clopidogrel, heparin or contrast.
• Inability to understand information or to provide informed consent.
• Haemorrhagic diathesis or known coagulopathy.
• Stent thrombosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deferred primary PCI.	Deferred stenting in primary PCI.	Deferred strategy in STEMI.
Conventional treatment.	Conventional primary PCI	Conventional primary PCI in STEMI.
IPost	Ischemic postconditioning.	Ischemic postconditioning in STEMI.

Primary Outcome Measures

Name	Time	Method
All cause mortality, heart failure (postconditioning)	2 years

Secondary Outcome Measures

Name	Time	Method
All cause mortality, myocardial infarction, repeat revascularisation and occurrence of definite stent thrombosis according to ARC definition within 1 year (deferred stent strategy)	1 year
Infarct size in relation to area at risk as determined by MRI after 3 month	3 month	Infarct size Salvage index

Trial Locations

Locations (5)

Department of Cardiology, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of Cardiology, Skejby University Hospital; 🇩🇰 Aarhus, Denmark

The Heart Center, Rigshospitalet, University of Copenhagen; 🇩🇰 Copenhagen, Denmark

Department of Cardiology, Gentofte University Hospital; 🇩🇰 Hellerup, Denmark

Department of Cardiology, Odense University Hospital; 🇩🇰 Odense, Denmark