PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE

Completed

Conditions: Stroke, Ischemic
Acute Coronary Syndrome

Interventions: Diagnostic Test: Coronary angiography

Registration Number: NCT03609385

Lead Sponsor: Charite University, Berlin, Germany

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 254

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke patients with elevated troponin	Coronary angiography	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

Primary Outcome Measures

Name	Time	Method
Presence of Myocardial Infarction	within seven days of admission to hospital	the diagnosis will be established by an independent endpoint committee

Secondary Outcome Measures

Name	Time	Method
Mortality	at one week and at three and twelve months after the initial event, at 12 months reported.	mortality will be recorded during the stay in hospital as well as after three and twelve months
Functional Outcome	at baseline, at one week and at three and twelve months after the initial event, 12 months reported	functional outcome will be evaluated using the modified Rankin scale (0-6 with greater scores indicating poorer functional outcome)
Cardiovascular Events	at one week and at three and twelve months after the initial event, 12 months reported	cardiovascular events include new stroke, transient ischemic attack and myocardial infarction and mortality

Trial Locations

Locations (28): Rhön-Klinikum Campus Bad Neustadt
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Bad Neustadt An Der Saale, Germany
Charité-Campus Benjamin Franklin
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Berlin, Germany
Charité-Campus Virchow Klinikum
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Berlin, Germany
Jüdisches Krankenhaus
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Berlin, Germany
Charité-Campus Mitte
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Berlin, Germany
Universitätsklinikum Bonn
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Bonn, Germany
Allgemeines Krankenhaus Celle
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Celle, Germany
Universitätsklinikum Dresden
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Dresden, Germany
Universitätsklinikum Frankfurt
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Frankfurt, Germany
Universitätsklinikum Erlangen
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Erlangen, Germany
Klinikum Friedrichshafen
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Friedrichshafen, Germany
Klinikum Fulda
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Fulda, Germany
Universitätsklinikum Greifswald
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Greifswald, Germany
Universitätsmedizin Göttingen
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Göttingen, Germany
Universitätsklinikum Hamburg-Eppendorf
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Hamburg, Germany
Universitätsklinikum Heidelberg
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Heidelberg, Germany
Universitätsklinikum Leipzig
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Leipzig, Germany
Universitätsklinikum Jena
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Jena, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
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Lübeck, Germany
Universitätsklinikum der Ludwig-Maximilians-Universität München
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Munich, Germany
Universitätsklinikum Magdeburg
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Magdeburg, Germany
Universitätsklinikum Mannheim
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Mannheim, Germany
Klinikum Nürnberg Süd
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Nürnberg, Germany
Technische Universität München (TUM)
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München, Germany
Klinikum Osnabrück
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Osnabrück, Germany
Universitätsmedizin Rostock
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Rostock, Germany
Universitätsklinikum Ulm
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Ulm, Germany
Universitätsklinikum Tübingen
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Tübingen, Germany