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The purpose of this research study is to find out whether PICSO (Pressure Controlled Coronary Sinus Occlusion), given concomitant to (NSTEMI) or following (STEMI) primary PCI and stenting, can improve final infarct size and myocardial function.
ACS patients, NSTEMI and STEMI, with a culprit lesion in the LAD will be treated according to standard treatment, PCI followed by stent placement, with or without PICSO therapy. In NSTEMI patients, PICSO therapy will be given during PCI and stenting for a minimum of 30 minutes or the duration of the PCI and stent procedure. In STEMI patients PICSO therapy will be given after successful primary percutaneous coronary intervention of a left anterior descending coronary artery culprit lesion. PICSO therapy is initiated prior to stent deployment and continued during stenting. The functional efficacy measures, related to the PICSO duration and coronary sinus pressures, will be stored on the PICSO Impulse console and analysed offline. The clinical efficacy measures, cardiac enzyme release during 24 hour following PCI, cardiac function, infarct size and level of microvascular obstruction will be assessed by cMRI. Patients will be followed for a maximum of 4 months after the primary PCI procedure
The study is designed to evaluate the effect of PICSO treatment concomitant to or following primary PCI in patients with anterior non ST-segment Elevation Myocardial Infarction or ST-segment Elevation Myocardial Infarction, in patients with a culprit lesion in the LAD on Infarct Size and myocardial function. There will be 2 phases in this study.
Phase 1 During Phase 1 of the study only NSTEMI patients will be recruited. After having given informed consent the patient will be scheduled for pPCI and stent placement. On the day of the procedure the PICSO catheter will be placed as described below (refer to PICSO Impulse catheter placement). After the PICSO therapy is started the standard pPCI and stent placement is performed. PICSO is continued at a minimum of 30 minutes or as long as the standard pPCI and stent placement takes.
Phase 2 During Phase 2 of the study only STEMI patients will be recruited. Immediately after successful restoration of the blood flow the PICSO Impulse catheter is introduced and placed as described below (Refer to PICSO Impulse catheter placement).
After correct positioning of the PICSO Impulse catheter, the 0,032" guide wire is removed. PICSO therapy is initiated and continued until a PICSO Quantity of 1000 mmHg is reached or a maximum of 60 minutes active treatment whatever comes first. With PICSO in treatment mode, the stent is deployed.
The clinical outcome data collected will be based on the site standards of care for NSTEMI and acute STEMI. Examinations include but are not limited to physical assessments, cardiac markers, ECG, laboratory results, x-rays, angiograms, cMRI and echocardiography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICSO | Active Comparator | Participants enrolled in the PICSO treatment Group will be treated with PICSO concomitant to pPCI in patients with anterior non ST-segment Elevation Myocardial Infarction or following pPCI in ST-segment Elevation Myocardial Infarction |
|
| Parallel control | No Intervention | Participants enrolled in will receive treatment based on the standard guidelines for treatment of a myocardial infarction. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICSO | Device | Pressure controlled Intermittent Coronary Pressure Occlusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Infarct Size assessed by cardiac MRI | Efficacy of PICSO treatment as assessed by means of infarct size reduction assessment, 4-months vs. 1 week post-primary PCI in comparison with a matched non-PICSO parallel control group | baseline and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Enzymatic Infarct Size | Peak Troponin level 12 hours after pPCI, in comparison with a matched non-PICSO parallel control group | 12 hours post PCI |
| Level of Microvascular Obstruction assessed by cardia MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Azfar Zaman, Prof. Dr. | Freeman Hospital, Newcastle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Heart and Chest Hospital | Liverpool | United Kingdom | ||||
| St Bartholomew's Hospital |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Microvascular Obstruction assessed by cardiac MRI on 2-5 days post pPCI
| 2-5 days post PCI |
| Absolute Infarct size assessment by cardiac MRI | Infarct size assessment by cardiac MRI (presented as % of Area at Risk, AAR, and % of LV) at 2-5 days and 120 ± 14 days post-primary PCI in comparison with a matched non-PICSO parallel control group. | baseline and 4 months |
| MACE | Occurrence of major adverse cardiac events (MACE) during follow-up | baseline to 4 months |
| London |
| United Kingdom |
| Freeman Hospital | Newcastle | United Kingdom |
| Northern General Hospital | Sheffield | United Kingdom |
| D009203 |
| Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |