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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-resuscitated myocardial infarction | diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial |
| |
| resuscitated myocardial infarction | diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diagnostic analysis of platelet function | Other | analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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All patients surviving the first night after resuscitation due to myocardial infarction
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| Name | Affiliation | Role |
|---|---|---|
| Dirk von Lewinski, MD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | 8010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14737006 | Background | McNicol A, Israels SJ. Platelets and anti-platelet therapy. J Pharmacol Sci. 2003 Dec;93(4):381-96. doi: 10.1254/jphs.93.381. | |
| 14592562 | Background | Tendera M, Wojakowski W. Role of antiplatelet drugs in the prevention of cardiovascular events. Thromb Res. 2003 Jun 15;110(5-6):355-9. doi: 10.1016/j.thromres.2003.08.003. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | AU*min | day 3 |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resuscitated MI | Death within the Observation period of 7 days; n=3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High on aspirin platelet reactivity | Blood and lymphatic system disorders | Systematic Assessment | High on aspirin platele reactivity defined as collagene AUC > 500 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assoc. Prof. Dr. Dirk von Lewinski | Medical University of Grazt | +43 316 385 | 80684 | dirk.von-lewinski@medunigraz.at |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 12796140 | Background | Gurbel PA, Bliden KP, Hiatt BL, O'Connor CM. Clopidogrel for coronary stenting: response variability, drug resistance, and the effect of pretreatment platelet reactivity. Circulation. 2003 Jun 17;107(23):2908-13. doi: 10.1161/01.CIR.0000072771.11429.83. Epub 2003 Jun 9. |
| 19550060 | Background | Puri KS, Suresh KR, Gogtay NJ, Thatte UM. Declaration of Helsinki, 2008: implications for stakeholders in research. J Postgrad Med. 2009 Apr-Jun;55(2):131-4. doi: 10.4103/0022-3859.52846. |
| 19007592 | Background | Siller-Matula JM, Lang I, Christ G, Jilma B. Calcium-channel blockers reduce the antiplatelet effect of clopidogrel. J Am Coll Cardiol. 2008 Nov 4;52(19):1557-63. doi: 10.1016/j.jacc.2008.07.055. |
| 30445678 | Derived | Pruller F, Bis L, Milke OL, Fruhwald F, Patzold S, Altmanninger-Sock S, Siller-Matula J, von Lewinski F, Ablasser K, Sacherer M, von Lewinski D. Cangrelor Induces More Potent Platelet Inhibition without Increasing Bleeding in Resuscitated Patients. J Clin Med. 2018 Nov 15;7(11):442. doi: 10.3390/jcm7110442. |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Collagen AUC day 1 | Aspirin reactivity was monitored by inducing platelet aggregation with 2 µg/mL collagen and 0.5 mmol L-1 arachidonic acid (AA, Chronolog Corp., Havertown, PA, USA), respectively. First measurement was on day one and thus represents baseline. | Median | Inter-Quartile Range | AU*min |
|
|
|
| Secondary | Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis | Posted | Count of Participants | Participants | 7 days |
|
|
|
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Non Resuscitated MI | Death within the Observation period of 7 days; n=0 | 0 | 77 | 0 | 77 | 0 | 77 |
|
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| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |