Pressure Controlled Intermittent Coronary Sinus Occlusion as an Adjunct to PCI in Acute Coronary Syndrome.
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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pressure Controlled Intermittent Coronary Sinus Occlusion as an Adjunct to PCI in Acute Coronary Syndrome. (An Observational Study Evaluating the Effect of PICSO Treatment Concomitant to pPCI in Patients With Anterior NSTEMI or Following pPCI in STEMI)|
- Change in Infarct Size assessed by cardiac MRI [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]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
- Enzymatic Infarct Size [ Time Frame: 12 hours post PCI ] [ Designated as safety issue: No ]Peak Troponin level 12 hours after pPCI, in comparison with a matched non-PICSO parallel control group
- Level of Microvascular Obstruction assessed by cardia MRI [ Time Frame: 2-5 days post PCI ] [ Designated as safety issue: No ]Microvascular Obstruction assessed by cardiac MRI on 2-5 days post pPCI
- Absolute Infarct size assessment by cardiac MRI [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]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.
- MACE [ Time Frame: baseline to 4 months ] [ Designated as safety issue: No ]Occurrence of major adverse cardiac events (MACE) during follow-up
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Active Comparator: PICSO
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
Pressure controlled Intermittent Coronary Pressure Occlusion
Other Name: PICSO Impulse System
No Intervention: Parallel control
Participants enrolled in will receive treatment based on the standard guidelines for treatment of a myocardial infarction.
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: only NSTEMI patients will be recruited.
- Phase 2: only STEMI patients will be recruited.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02197325
|Liverpool Heart and Chest Hospital||Recruiting|
|Liverpool, United Kingdom|
|Contact: Nick Palmer, MD firstname.lastname@example.org|
|St Bartholomew's Hospital||Recruiting|
|London, United Kingdom|
|Contact: Ajay Jain, MD Ajay.Jain@bartshealth.nhs.uk|
|Newcastle, United Kingdom|
|Contact: Azfar Zaman, Prof. +44 1912336161 email@example.com|
|Principal Investigator: Azfar Zaman, Prof.|
|Northern General Hospital||Recruiting|
|Sheffield, United Kingdom|
|Contact: Ever Grech, MD firstname.lastname@example.org|
|Principal Investigator:||Azfar Zaman, Prof. Dr.||Freeman Hospital Newcastle|