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

ST Segment Elevation Myocardial Infarction Clinical Trial

— DANAMI-3  

Official title:

A Randomised Comparison of the Clinical Outcome After Postconditioning or Deferred Stent Implantation Versus Conventional Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01435408
• Other study ID #: DANAMI-3
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2011
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study focuses on Cardioprotective strategies.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 2024
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST Segment Elevation Myocardial Infarction

Intervention

Other:
• Conventional primary PCI
Conventional primary PCI in STEMI with implantation of DES.
• Ischemic postconditioning.
Primary PCI in STEMI with implantation of DES. Following re-opening of the culprit artery mechanical postconditioning with 4 cycles of 30/30 sec. reperfusion/re-occlusion i performed.
• Deferred stenting in primary PCI.
In STEMI re-opening of the artery with guidewire/thrombectomy/small size balloon inflation DES stenting is postponed for 48 hours.

Locations

Country	Name	City	State
Denmark	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

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TIMI flow		postprocedure
Other	ST-segment resolution		90 min postprocedure
Other	Wall motion index (echo)		1 year
Other	LVEF (MRI)		90 days
Other	Infarct size (MRI)		90 days
Other	Microvascular obstruction (MVO)		within 48 hours
Other	Quality of life		1 year
Primary	All cause mortality, heart failure (postconditioning)		2 years
Secondary	Infarct size in relation to area at risk as determined by MRI after 3 month	Infarct size Salvage index	3 month
Secondary	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