Acute ST Segment Elevation Myocardial Infarction
Conditions
Brief summary
Approx. 65% of resuscitated patients at the intensive care unit for internal medicine are due to myocardial infarction. Almost all patients are initially diagnosed and treated in the cath lab. Therapy usually consists of one or more stent implantations. After implantation of a coronary stent, dual platelet inhibition is necessary for 12 months. Insufficient platelet inhibition causes an pronounced increase in risk of stent thrombosis. Therefore, knowledge of the individual platelet function is valuable. Several factors potentially promote a delayed or reduced mode of action of platelet function inhibitors in resuscitated patients: 1. oral administration is impossible and medication needs to be administered via a gastric line. 2. gastric absorption is delayed after resuscitation 3. according to current guidelines patients are treated with therapeutic hypothermia. Including the time of rewarming cooling period is \ 48h
Detailed description
Patients after successful resuscitation associated to a myocardial infarction will be included into the study the morning after the index event. Patients get dual platelet inhibition at the discretion of the interventionist. Patients are treated with therapeutic hypothermia according to the local Standard operating procedure for 24h and rewarming is performed within an additional 20h. Platelet function is measured every morning and Aspirin mediated as well as P2Y12 (purinergic G protein-coupled receptors-12)-inhibition mediated platelet function inhibition is recorded. All relevant clinical data including APACHE (Acute Physiology and Chronic Health Evaluation) and SOFA ( Sequential Organ Failure Assessment score) scores are collected. The degree of platelet inhibition over time (7 days) and differences between the three drugs tested will be evaluated by optical aggregometry and by using the commercial VerifyNow test system.
Interventions
OTHERdiagnostic analysis of platelet function
analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique
Sponsors
Medical University of Graz
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Myocardial infarction * dual platelet inhibition * resuscitation * therapeutic hypothermia
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet Inhibition Measured With Optical Aggregometry | day 3 | Median (Inter-Quartile Range) Collagen AUC values on Day 3 measured with optical aggregometry The more light signal is detected, the better thrombocyte function is. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis | 7 days |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-resuscitated Myocardial Infarction diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial
diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique | 77 |
| Resuscitated Myocardial Infarction diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria
diagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique | 22 |
| Total | 99 |
Baseline characteristics
| Characteristic | Non-resuscitated Myocardial Infarction | Resuscitated Myocardial Infarction | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 38 Participants | 9 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 13 Participants | 52 Participants |
| Age, Continuous | 64.3 years | 65 years | 64.5 years |
| Collagen AUC day 1 | 219 AU*min | 69.5 AU*min | 185.8 AU*min |
| Region of Enrollment Austria | 77 participants | 22 participants | 99 participants |
| Sex: Female, Male Female | 18 Participants | 3 Participants | 21 Participants |
| Sex: Female, Male Male | 59 Participants | 19 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 22 | 0 / 77 |
| other Total, other adverse events | 0 / 22 | 0 / 77 |
| serious Total, serious adverse events | 0 / 22 | 0 / 77 |
Outcome results
Primary
Platelet Inhibition Measured With Optical Aggregometry
Median (Inter-Quartile Range) Collagen AUC values on Day 3 measured with optical aggregometry The more light signal is detected, the better thrombocyte function is.
Time frame: day 3
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-resuscitated Myocardial Infarction | Platelet Inhibition Measured With Optical Aggregometry | 109 AU*min |
| Resuscitated Myocardial Infarction | Platelet Inhibition Measured With Optical Aggregometry | 253.8 AU*min |
Secondary
Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-resuscitated Myocardial Infarction | Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis | 0 Participants |
| Resuscitated Myocardial Infarction | Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis | 3 Participants |