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Recruiting NCT04775914

STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance

No phase Interventional ST Elevation Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PCI + Ischemic conditioning, Stent with ultrasound.
Who it may be relevant to
Registry conditions: ST Elevation Myocardial Infarction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The STEMI Optimization Trial - Ischemic Postconditioning (DANAMI4-iPOST) and Intravascular Ultrasound Guided PCI in STEMI (DANAMI4-iSTEMI)

Overview

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.

Interventions

  • Procedure PCI + Ischemic conditioning
    IPOST is repeated for 4 cycles (60 sec obstruction followed by 60 sec perfusion each) and followed by stent implantation with a 1.1/1.0 ratio of stent diameter/reference vessel diameter and a stent length sufficient to cover the entire lesion from healthy to healthy area of the vessel. During the first cycle of re-occlusion of full vessel occlusion is secured by a small injection of contrast.
  • Procedure Stent with ultrasound
    IVUS catheters are to be advanced at least 20 mm distal to the culprit lesion. After administration of intracoronary nitroglycerine, an IVUS-pullback is to be performed at 0.5mm/second using a commercially available imaging system. Stent size and landing zones are decided based on the IVUS.

Primary outcome measures

  • iPOST [Time frame: Until expected number of events are adjudicated up til 3 years]
  • iSTEMI (IVUS) [Time frame: Until expected number of events are adjudicated up til 3 years]
Secondary outcome measures (12)
  • iSTEMI (IVUS) [Time frame: Until expected number of events are adjudicated 3 years]
  • iSTEMI (IVUS) [Time frame: Until expected number of events are adjudicated 3 years]
  • iSTEMI (IVUS) [Time frame: Until expected number of events are adjudicated 3 years]
  • iSTEMI (IVUS) [Time frame: Until expected number of events are adjudicated 3 years]
  • iSTEMI (IVUS) [Time frame: Until expected number of events are adjudicated 3 years]
  • iSTEMI (IVUS) [Time frame: Until expected number of events are adjudicated 3 years]
  • iSTEMI (IVUS) [Time frame: Until expected number of events are adjudicated 3 years]
  • iPOST [Time frame: Until expected number of events are adjudicated 3 years]
  • iPOST [Time frame: Until expected number of events are adjudicated 3 years]
  • iPOST [Time frame: Until expected number of events are adjudicated 3 years]
  • iPOST [Time frame: Until expected number of events are adjudicated 3 years]
  • iPOST [Time frame: 1 year]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Heart Center, Rigshospitalet — Copenhagen

Identifiers

NCT: NCT04775914 · H-18051256b

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗