ST Elevation Myocardial InfarctionDANAMI4NCT04775914
STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance
A study testing PCI + Ischemic conditioning and Stent with ultrasound in people with ST Elevation Myocardial Infarction, run by Thomas Engstrom at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- PCI + Ischemic conditioning and Stent with ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2021to 1 Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Heart Center, Rigshospitalet
Copenhagen, Capital Region, 2100
Thomas Engstrom, MD PhD DSci, +4535458444, thomas.engstroem@rh.regionh.dk
Jacob Lønborg, +4535458176, jacob.thomsen.loenborg01@regionh.dk
About this study
Official title: The STEMI Optimization Trial - Ischemic Postconditioning (DANAMI4-iPOST) and Intravascular Ultrasound Guided PCI in STEMI (DANAMI4-iSTEMI)
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.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- PCI + Ischemic conditioning, Stent with ultrasound
- Keywords
- Primary PCI, Coronary angiography, Intravascular ultra sound (IVUS)
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI + Ischemic conditioningProcedure or surgery
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 ultrasoundProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PCI standard | Active comparator | Not described Receives: Procedure: PCI + Ischemic conditioning |
| PCI standard + ischemic conditioning | Experimental | Not described Receives: Procedure: PCI + Ischemic conditioning |
| Stent with ultrasound | Experimental | Not described Receives: Procedure: Stent with ultrasound |
| Stent without ultrasound | Active comparator | Not described Receives: Procedure: Stent with ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
iPOST
Number of participants that experience all-cause mortality or hospitalization for heart failure
Measured: Until expected number of events are adjudicated up til 3 years
iSTEMI (IVUS)
Number of participants that experience all-cause mortality, unplanned ischemia-driven revascularization and new myocardial infarction
Measured: Until expected number of events are adjudicated up til 3 years
Secondary outcomes (12)
iSTEMI (IVUS)
Target vessel failure (cardiac mortality, unplanned ischemia driven target vessel revascularization or target vessel myocardial infarction
Measured: Until expected number of events are adjudicated 3 years
iSTEMI (IVUS)
Individual components of the primary endpoint
Measured: Until expected number of events are adjudicated 3 years
iSTEMI (IVUS)
Cardiac mortality
Measured: Until expected number of events are adjudicated 3 years
iSTEMI (IVUS)
Unplanned ischemia driven target vessel revascularization
Measured: Until expected number of events are adjudicated 3 years
iSTEMI (IVUS)
Unplanned ischemia driven target vessel myocardial infarction
Measured: Until expected number of events are adjudicated 3 years
iSTEMI (IVUS)
Unplanned ischemia driven target lesion revascularization
Measured: Until expected number of events are adjudicated 3 years
iSTEMI (IVUS)
Definite/probable stent-thrombosis
Measured: Until expected number of events are adjudicated 3 years
iPOST
Individual components of the primary endpoint
Measured: Until expected number of events are adjudicated 3 years
iPOST
Cardiac mortality
Measured: Until expected number of events are adjudicated 3 years
iPOST
Ischemia driven target vessel revascularization
Measured: Until expected number of events are adjudicated 3 years
iPOST
New myocardial infarction
Measured: Until expected number of events are adjudicated 3 years
iPOST
Quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial As a second randomization to the iPOST2 trial (ID: H-180512561,NCT03787745) patients are randomized 1:1 to either a) receiving ultrasound guidance before and after stent placement or b) no ultrasound, independently of randomization in the iPOST2 trial. The iPOST2 trial was initiated February 2019.
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Engstrom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Engstrom, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Thomas Engstrøm, MD PhD DMSci, Study chair, Copenhagen University Hospital, RigshospitaletJacob Lønborg, MD PhD DMSci, Study chair, Copenhagen University Hospital, RigshospitaletFrancis Joshi, Md, PhD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775914
- Sponsor's protocol ID
- H-18051256b
- Acronym
- DANAMI4
- Status last verified
- May 2025
- First submitted
- 17 Feb 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STEMI Optimization Trial - Ischemic Postconditioning (DANAMI4-iPOST) and Intravascular Ultrasound Guided PCI in STEMI (DANAMI4-iSTEMI)
- ClinicalTrials.gov ID
- NCT04775914
- Acronym / sponsor ID
- DANAMI4 / H-18051256b
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- Primary PCI, Coronary angiography, Intravascular ultra sound (IVUS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Thomas EngstromUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2031 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2x2 factorial As a second randomization to the iPOST2 trial (ID: H-180512561,NCT03787745) patients are randomized 1:1 to either a) receiving ultrasound guidance before and after stent placement or b) no ultrasound, independently of randomization in the iPOST2 trial. The iPOST2 trial was initiated February 2019.
| Arm | Type | Receives |
|---|---|---|
| PCI standard | Active comparator | Procedure: PCI + Ischemic conditioning |
| PCI standard + ischemic conditioning | Experimental | Procedure: PCI + Ischemic conditioning |
| Stent with ultrasound | Experimental | Procedure: Stent with ultrasound |
| Stent without ultrasound | Active comparator | Procedure: Stent with ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI + Ischemic conditioningIPOST 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 or surgery | PCI standard, PCI standard + ischemic conditioning |
| Stent with ultrasoundIVUS 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. | Procedure or surgery | Stent with ultrasound, Stent without ultrasound |
Primary outcome
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
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
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Engstrøm, MD PhD DMSci study chair
Copenhagen University Hospital, Rigshospitalet
Jacob Lønborg, MD PhD DMSci study chair
Copenhagen University Hospital, Rigshospitalet
Francis Joshi, Md, PhD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI + Ischemic conditioning and Stent with ultrasound in people with ST Elevation Myocardial Infarction, run by Thomas Engstrom at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Engstrøm, MD PhD DSci (+45 3545 8444, Thomas.Engstroem@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iPOST (time frame: Until expected number of events are adjudicated up til 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.