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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01435408
Acronym
DANAMI-3
Enrollment
2000
Registered
2011-09-16
Start date
2011-04-30
Completion date
2024-12-31
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

STEMI, Ischemic postconditioning, Deferred stenting, Primary PCI

Brief summary

This study focuses on Cardioprotective strategies.

Interventions

OTHERConventional primary PCI

Conventional primary PCI in STEMI with implantation of DES.

OTHERIschemic 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.

OTHERDeferred 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.

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
All cause mortality, heart failure (postconditioning)2 years

Secondary

MeasureTime frameDescription
Infarct size in relation to area at risk as determined by MRI after 3 month3 monthInfarct size Salvage index
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

Other

MeasureTime frame
LVEF (MRI)90 days
Infarct size (MRI)90 days
TIMI flowpostprocedure
Quality of life1 year
Microvascular obstruction (MVO)within 48 hours
ST-segment resolution90 min postprocedure
Wall motion index (echo)1 year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026