ST Elevation Myocardial Infarction
Conditions
Keywords
Primary PCI, Coronary angiography, Intravascular ultra sound (IVUS)
Brief 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.
Interventions
PROCEDUREPCI + 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.
PROCEDUREStent 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.
Sponsors
Thomas Engstrom
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| iPOST | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| iSTEMI (IVUS) | 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 |
| iPOST | Until expected number of events are adjudicated 3 years | Individual components of the primary endpoint |
Countries
Denmark
Contacts
CONTACTThomas Engstrøm, MD PhD DSci
CONTACTJacob Lønborg, MD PhD DMSci
STUDY_CHAIRThomas Engstrøm, MD PhD DMSci
Rigshospitalet, Denmark
STUDY_CHAIRJacob Lønborg, MD PhD DMSci
Rigshospitalet, Denmark
STUDY_CHAIRFrancis Joshi, Md, PhD
Rigshospitalet, Denmark
Outcome results
None listed