Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCI standard | Active Comparator |
| |
| PCI standard + ischemic conditioning | Experimental |
| |
| Stent with ultrasound | Experimental |
| |
| Stent without ultrasound | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| iSTEMI (IVUS) |
| Measure | Description | Time Frame |
|---|---|---|
| iSTEMI (IVUS) | Hospitalization for heart failure | Until expected number of events are adjudicated 3 years |
| iSTEMI (IVUS) | Stroke | Until expected number of events are adjudicated 3 years |
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Engstrøm, MD PhD DSci | Contact | +45 3545 8444 | Thomas.Engstroem@regionh.dk | |
| Jacob Lønborg, MD PhD DMSci | Contact | +45 3545 8176 | jacob.thomsen.loenborg01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Engstrøm, MD PhD DMSci | Rigshospitalet, Denmark | Study Chair |
| Jacob Lønborg, MD PhD DMSci | Rigshospitalet, Denmark | Study Chair |
| Francis Joshi, Md, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center, Rigshospitalet | Recruiting | Copenhagen | Capital Region | 2100 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015607 | Stents |
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
Individual components of the primary endpoint
| Until expected number of events are adjudicated 3 years |
| iSTEMI (IVUS) | Cardiac mortality | Until expected number of events are adjudicated 3 years |
| iSTEMI (IVUS) | Unplanned ischemia driven target vessel revascularization | Until expected number of events are adjudicated 3 years |
| iSTEMI (IVUS) | Unplanned ischemia driven target vessel myocardial infarction | Until expected number of events are adjudicated 3 years |
| iSTEMI (IVUS) | Unplanned ischemia driven target lesion revascularization | Until expected number of events are adjudicated 3 years |
| iSTEMI (IVUS) | Definite/probable stent-thrombosis | Until expected number of events are adjudicated 3 years |
| iPOST | Individual components of the primary endpoint | Until expected number of events are adjudicated 3 years |
| iPOST | Cardiac mortality | Until expected number of events are adjudicated 3 years |
| iPOST | Ischemia driven target vessel revascularization | Until expected number of events are adjudicated 3 years |
| iPOST | New myocardial infarction | Until expected number of events are adjudicated 3 years |
| iPOST | Quality of life | 1 year |
| iSTEMI (IVUS) | Bleeding | Until expected number of events are adjudicated 3 years |
| iSTEMI (IVUS) | Quality of life | 1 year |
| iPOST | Any ischemia driven revascularization | Until expected number of events are adjudicated 3 years |
| iPOST | Bleeding | Until expected number of events are adjudicated 3 years |
| iPOST | Stroke | Until expected number of events are adjudicated 3 years |
| iPOST | Ventricular arrythmia | Until expected number of events are adjudicated 3 years |
| iPOST | ICD | Until expected number of events are adjudicated 3 years |
| Rigshospitalet, Denmark |
| Study Chair |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D011840 |
| Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |