STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance (DANAMI4)

Thomas Engstrom

Status: Enrolling

Conditions: ST Elevation Myocardial Infarction

Treatments: Procedure: PCI + Ischemic conditioning; Procedure: Stent with ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04775914

H-18051256b

Details and patient eligibility

About

The purpose of is study is to investigate whether ischemic postconditioning (iPOST) and intravascular ultrasound-guided (IVUS) percutaneous coronary intervention (PCI) improve the clinical outcome of patients with ST-segment elevation myocardial infarction treated with primary PCI.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age ≥18 years
• Acute onset of chest pain with <12 hours duration
• STEMI as characterized by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV ST-segment elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior AMI.

Exclusion Criteria (iPOST2):

Pre-PCI TIMI flow 0 or 1 Potential pregnancy Inability to provide informed consent Unwillingness to consent Unavoidable to use thrombectomy Spontaneous coronary artery dissection Time from symptoms onset to PPCI > 12 hours Culprit in bypass graft Other reason for not including the patient

Exclusion Criteria (iSTEMI):

Potential pregnancy Inability to understand information in order to provide informed consent Unwillingness to consent Spontaneous coronary artery dissection Time from symptoms inset to PPCI > 12 hours Culprit in bypass graft Other reason

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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2,500 participants in 4 patient groups

PCI standard

Active Comparator group

Treatment:

Procedure: PCI + Ischemic conditioning

PCI standard + ischemic conditioning

Experimental group

Treatment:

Procedure: PCI + Ischemic conditioning

Stent with ultrasound

Experimental group

Treatment:

Procedure: Stent with ultrasound

Stent without ultrasound

Active Comparator group

Treatment:

Procedure: Stent with ultrasound