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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04775914
Other study ID # H-18051256b
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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