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Recruiting

NCT Number: NCT04775914

STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance

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.

Recruiting

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Key information

Conditions

ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Center, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location status: Recruiting

Location contact

Francis Joshi, MD PhD

PRINCIPAL_INVESTIGATOR

Jacob Lønborg

CONTACT

[email protected]

+4535458176

Jacob T Lønborg, MD PhD DMSci

PRINCIPAL_INVESTIGATOR

Thomas Engstrom, MD PhD DSci

CONTACT

[email protected]

+4535458444

Thomas Engstrom, MD PhD DSci

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCI + Ischemic conditioning

Procedure

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.

Stent with ultrasound

Procedure

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 outcomes

  1. iPOST

    Time frame: Until expected number of events are adjudicated up til 3 years

    Number of participants that experience all-cause mortality or hospitalization for heart failure

  2. iSTEMI (IVUS)

    Time frame: Until expected number of events are adjudicated up til 3 years

    Number of participants that experience all-cause mortality, unplanned ischemia-driven revascularization and new myocardial infarction

Secondary outcomes

  1. iSTEMI (IVUS)

    Time frame: Until expected number of events are adjudicated 3 years

    Target vessel failure (cardiac mortality, unplanned ischemia driven target vessel revascularization or target vessel myocardial infarction

  2. iSTEMI (IVUS)

    Time frame: Until expected number of events are adjudicated 3 years

    Individual components of the primary endpoint

  3. iSTEMI (IVUS)

    Time frame: Until expected number of events are adjudicated 3 years

    Cardiac mortality

  4. iSTEMI (IVUS)

    Time frame: Until expected number of events are adjudicated 3 years

    Unplanned ischemia driven target vessel revascularization

  5. iSTEMI (IVUS)

    Time frame: Until expected number of events are adjudicated 3 years

    Unplanned ischemia driven target vessel myocardial infarction

  6. iSTEMI (IVUS)

    Time frame: Until expected number of events are adjudicated 3 years

    Unplanned ischemia driven target lesion revascularization

  7. iSTEMI (IVUS)

    Time frame: Until expected number of events are adjudicated 3 years

    Definite/probable stent-thrombosis

  8. iPOST

    Time frame: Until expected number of events are adjudicated 3 years

    Individual components of the primary endpoint

  9. iPOST

    Time frame: Until expected number of events are adjudicated 3 years

    Cardiac mortality

  10. iPOST

    Time frame: Until expected number of events are adjudicated 3 years

    Ischemia driven target vessel revascularization

  11. iPOST

    Time frame: Until expected number of events are adjudicated 3 years

    New myocardial infarction

  12. iPOST

    Time frame: 1 year

    Quality of life

Other outcomes

  1. iSTEMI (IVUS)

    Time frame: Until expected number of events are adjudicated 3 years

    Hospitalization for heart failure

  2. iSTEMI (IVUS)

    Time frame: Until expected number of events are adjudicated 3 years

    Stroke

  3. iSTEMI (IVUS)

    Time frame: Until expected number of events are adjudicated 3 years

    Bleeding

  4. iSTEMI (IVUS)

    Time frame: 1 year

    Quality of life

  5. iPOST

    Time frame: Until expected number of events are adjudicated 3 years

    Any ischemia driven revascularization

  6. iPOST

    Time frame: Until expected number of events are adjudicated 3 years

    Bleeding

  7. iPOST

    Time frame: Until expected number of events are adjudicated 3 years

    Stroke

  8. iPOST

    Time frame: Until expected number of events are adjudicated 3 years

    Ventricular arrythmia

  9. iPOST

    Time frame: Until expected number of events are adjudicated 3 years

    ICD

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob Lønborg, MD PhD DMSci

CONTACT

[email protected]

+45 3545 8176

Thomas Engstrøm, MD PhD DSci

CONTACT

[email protected]

+45 3545 8444

Sponsors and collaborators

Lead sponsor

Thomas Engstrom

Other

Registry information

Official study title

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

Acronym: DANAMI4

Important dates

Study start
2021
Primary completion
2027
Study completion
2031
First posted
Mar 1, 2021
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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