STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance

ST Elevation Myocardial Infarction Clinical Trial

— DANAMI4  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04775914
• Other study ID #: H-18051256b
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: February 1, 2031

Study information

• Verified date: December 2023
• Source: Rigshospitalet, Denmark
• Contact: Thomas Engstrøm, MD PhD DSci
• Phone: +45 3545 8444
• Email: Thomas.Engstroem[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: February 1, 2031
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Heart Center, Rigshospitalet	Copenhagen	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Engstrom

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	iSTEMI (IVUS)	Hospitalization for heart failure	Until expected number of events are adjudicated 3 years
Other	iSTEMI (IVUS)	Stroke	Until expected number of events are adjudicated 3 years
Other	iSTEMI (IVUS)	Bleeding	Until expected number of events are adjudicated 3 years
Other	iSTEMI (IVUS)	Quality of life	1 year
Other	iPOST	Any ischemia driven revascularization	Until expected number of events are adjudicated 3 years
Other	iPOST	Bleeding	Until expected number of events are adjudicated 3 years
Other	iPOST	Stroke	Until expected number of events are adjudicated 3 years
Other	iPOST	Ventricular arrythmia	Until expected number of events are adjudicated 3 years
Other	iPOST	ICD	Until expected number of events are adjudicated 3 years
Primary	iPOST	Number of participants that experience all-cause mortality or hospitalization for heart failure	Until expected number of events are adjudicated up til 3 years
Primary	iSTEMI (IVUS)	Number of participants that experience all-cause mortality, unplanned ischemia-driven revascularization and new myocardial infarction	Until expected number of events are adjudicated up til 3 years
Secondary	iSTEMI (IVUS)	Target vessel failure (cardiac mortality, unplanned ischemia driven target vessel revascularization or target vessel myocardial infarction	Until expected number of events are adjudicated 3 years
Secondary	iSTEMI (IVUS)	Individual components of the primary endpoint	Until expected number of events are adjudicated 3 years
Secondary	iSTEMI (IVUS)	Cardiac mortality	Until expected number of events are adjudicated 3 years
Secondary	iSTEMI (IVUS)	Unplanned ischemia driven target vessel revascularization	Until expected number of events are adjudicated 3 years
Secondary	iSTEMI (IVUS)	Unplanned ischemia driven target vessel myocardial infarction	Until expected number of events are adjudicated 3 years
Secondary	iSTEMI (IVUS)	Unplanned ischemia driven target lesion revascularization	Until expected number of events are adjudicated 3 years
Secondary	iSTEMI (IVUS)	Definite/probable stent-thrombosis	Until expected number of events are adjudicated 3 years
Secondary	iPOST	Individual components of the primary endpoint	Until expected number of events are adjudicated 3 years
Secondary	iPOST	Cardiac mortality	Until expected number of events are adjudicated 3 years
Secondary	iPOST	Ischemia driven target vessel revascularization	Until expected number of events are adjudicated 3 years
Secondary	iPOST	New myocardial infarction	Until expected number of events are adjudicated 3 years
Secondary	iPOST	Quality of life	1 year