PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE

Study Overview
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Brief Summary
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The primary goal of the PRAISE study is to develop a diagnostic algorithm that allows the prediction of acute coronary syndrome in stroke patients with elevated levels of cardiac troponin.

Detailed Description
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Elevation of cardiac troponin can be found in about 30% of patients with acute ischemic stroke (depending on the assay used). Elevated troponin indicates increased mortality in stroke patients. There is currently little evidence regarding the ideal care of these patients. The investigators know from previous studies that approximately 25% of acute stroke patients with elevated levels of cardiac troponin have culprit lesions on coronary angiogram. The primary goal of the PRAISE study is to develop a diagnostic algorithm that allows the prediction of acute coronary syndrome in stroke patients. To achieve this, clinical symptoms, troponin levels as well as findings on EKG, echocardiography and coronary angiography will be systematically evaluated. The PRAISE study is a multicenter study with more than 20 sites in Germany. Joint funding will be provided by DZHK (German center of cardiovascular research) und DZNE (German center of neurodegenerative diseases). Acute ischaemic stroke patients with elevated troponin are eligible for participation in the study. The primary endpoint is the diagnosis of acute coronary syndrome as established by an independent endpoint committee.

Official Title
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PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE

Conditions
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Stroke, Ischemic, Acute Coronary Syndrome

Intervention / Treatment
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* Diagnostic Test: Coronary angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of ischemic stroke based on clinical and imaging information (CT or MRI) diagnosis of transient ischemic attack if the initial focal neurological deficit has been examined by a neurologist and if the ABCD2-score is ≥ 4 Elevation of high-sensitive cardiac troponins according to the rule-in/rule-out algorithm of the 2015 ESC guidelines for NSTE-ACS, i.e. highly abnormal troponin at 0 hours (> 52ng/l if hs-cTnT, Elecsys-Assay, or > 52ng/l, if hs-cTnI; Architect-Assay, or > 107 ng/l, if hs-cTnI. Dimension Vista Assay) or dynamic change > 20% of the initial value at re-test after 3 hours with at least one value above the 99th percentile of a healthy reference population ability to give informed consent onset of symptoms < 72 hours prior to hospital admission Exclusion Criteria: renal insufficiency (GFR < 30 ml/min/m²) contraindications for coronary angiography (e.g. manifest hyperthyroidism, allergy to contrast agent) lesion size > 100 ml (either on Diffusion Weighted Imaging on cMRI or on CT if CT is performed > 24 hours after onset) or ASPECTS score < 7 (on CT if CT is performed < 24 hours after onset) Premorbid degree of dependence (mRS > 3) pregnancy or breast-feeding limited life expectancy < 1 year consent to participate in the study given > 72 hours after hospital admission

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stroke patients with elevated troponin<br>Patients with acute ischemic stroke (confirmed by cerebral imaging) and cardiac troponin values > 52 ng/l or troponin values > 14 ng/l and dynamic change > 20% will undergo coronary angiography | Diagnostic Test: Coronary angiography<br>* In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of acute coronary syndrome | the diagnosis will be established by an independent endpoint committee | within seven days of admission to hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | mortality will be recorded during the stay in hospital as well as after three and twelve months | at one week and at three and twelve months after the initial event | 
| functional outcome | functional outcome will be evaluated using the modified Rankin scale (0-6 with greater scores indicating poorer functional outcome) | at baseline, at one week and at three and twelve months after the initial event | 
| cardiovascular events | cardiovascular events include new stroke, transient ischemic attack and myocardial infarction | at one week and at three and twelve months after the initial event | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, troponin, acute coronary syndrome, culprit lesion