Clinical trial NCT01493037: PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention
Official title: Pressure Controlled Intermittent Coronary Sinus Occlusion in Patients With ST Segment Elevation Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention: Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST Elevation (STEMI) Myocardial Infarction
Keywords: STEMI
PICSO
Coronary Sinus
Involving Left Anterior Descending Coronary Artery
Lead sponsor: Miracor Medical SA
Sponsor class: INDUSTRY
First posted: 2011-12-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective multi-center study in which patients with an acute heart attack (in the left anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept study designed to document the safety and feasibility of the Pressure Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse system.


Eligibility criteria: Inclusion Criteria:

* First time anterior STEMI defined by the following:

  * Symptoms of myocardial ischemia \> 30 minutes and \< 12 hours
  * ST-segment elevation \> 1mm (\> 0.1 mV) in two contiguous precordial leads in the anterior territory on a 12-lead ECG
* Uncomplicated PCI of a LAD culprit lesion (defined as angioplasty followed by stent placement or direct stenting without the occurrence of an adverse event(s) that would preclude further study participation, such as major bleeding, perforation, hypotension, pulmonary edema or instability that in the judgement of the investigator preclude participation in the trial)

Exclusion Criteria:

* Younger than 18 years of age
* Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct
* Left main coronary artery culprit lesion
* Additional stenosis in the LAD for which PCI or CABG is likely to be needed in the next 6 months and which is not treated during the index procedure
* Cardiogenic shock (systolic blood pressure ≤90 mmHg in spite of conservative measures) or pulmonary edema (O2 saturation \<90% by pulse oximetry and the presence of rales or crackles)
* Cardiac arrest requiring chest compression or resuscitation
* Anatomical complications limit capacity to place PICSO Impulse device or achieve stable catheter placement or occlude coronary sinus
* Known renal disease (GFR \< 30 mL/min/1.73m2) or dialysis
* History of stroke, TIA or reversible ischemic neurological disease within last 6 months
* Left bundle branch block
* Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
* Presence of any lead in the coronary sinus
* Active or treated malignancies in the last 12 months
* Previous coronary artery bypass graft surgery
* Known severe anemia (Hgb \< 10 g/dL or \< 6.2 mmol/L)
* Known platelet count \< 100,000, known coagulopathy or bleeding diathesis, or unwilling to accept transfusions
* Participation in another ongoing clinical study
* Women of child-bearing age
* Non-cardiac comorbidities and life expectancy \< 1 year
* Legal incompetence
* A condition that, in the opinion of the Investigator, precludes participation, including compliance with all follow-up procedures
* No dependents neither to the sponsor nor to the investigator

Primary outcomes:
measure: Successful delivery of PICSO treatment
timeFrame: 90 minutes
Secondary outcomes:
measure: MRI measurement of infarct size
timeFrame: 4 months
measure: Assessment of left ventricular function
timeFrame: 4 months
measure: Assessment of microvascular perfusion
timeFrame: 4 months
measure: Resolution of ST-segment elevation
timeFrame: 24 hours
measure: Measurement of ST segment time curve area
timeFrame: 3 hours
measure: Number of adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center - University of Amsterdam
city: Breda
country: Netherlands
facility: Amphia Hospital
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jan J Piek, Professor
role: PRINCIPAL_INVESTIGATOR
References: