Clinical trial NCT03609385: PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE
Official title: PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Acute Coronary Syndrome
Keywords: stroke
troponin
acute coronary syndrome
culprit lesion
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
name: German Center for Neurodegenerative Diseases (DZNE)
First posted: 2018-08-01
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients with acute ischemic stroke admitted to the participating sites will be systematically screened for eligibility

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of Myocardial Infarction
timeFrame: within seven days of admission to hospital
Secondary outcomes:
measure: Mortality
timeFrame: at one week and at three and twelve months after the initial event, at 12 months reported.
measure: Functional Outcome
timeFrame: at baseline, at one week and at three and twelve months after the initial event, 12 months reported
measure: Cardiovascular Events
timeFrame: at one week and at three and twelve months after the initial event, 12 months reported
Other outcomes:
Locations:
city: Bad Neustadt An Der Saale
country: Germany
facility: Rhön-Klinikum Campus Bad Neustadt
city: Berlin
country: Germany
facility: Charité-Campus Mitte
city: Berlin
country: Germany
facility: Charité-Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charité-Campus Virchow Klinikum
city: Berlin
country: Germany
facility: Jüdisches Krankenhaus
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Celle
country: Germany
facility: Allgemeines Krankenhaus Celle
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Friedrichshafen
country: Germany
facility: Klinikum Friedrichshafen
city: Fulda
country: Germany
facility: Klinikum Fulda
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Munich
country: Germany
facility: Universitätsklinikum der Ludwig-Maximilians-Universität München
city: München
country: Germany
facility: Technische Universität München (TUM)
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: Charite University, Berlin, Germany
name: Matthias Endres, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Ulf Landmesser, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Christian Nolte, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nolte CH, von Rennenberg R, Litmeier S, Scheitz JF, Leistner DM, Blankenberg S, Dichgans M, Katus H, Petzold GC, Pieske B, Regitz-Zagrosek V, Wegscheider K, Zeiher AM, Landmesser U, Endres M. PRediction of acute coronary syndrome in acute ischemic StrokE (PRAISE) - protocol of a prospective, multicenter trial with central reading and predefined endpoints. BMC Neurol. 2020 Aug 27;20(1):318. doi: 10.1186/s12883-020-01903-0.
citation: Nolte CH, von Rennenberg R, Litmeier S, Leistner DM, Szabo K, Baumann S, Mengel A, Michalski D, Siepmann T, Blankenberg S, Petzold GC, Dichgans M, Katus H, Pieske B, Regitz-Zagrosek V, Braemswig TB, Rangus I, Pepic A, Vettorazzi E, Zeiher AM, Scheitz JF, Wegscheider K, Landmesser U, Endres M. Type 1 Myocardial Infarction in Patients With Acute Ischemic Stroke. JAMA Neurol. 2024 Jul 1;81(7):703-711. doi: 10.1001/jamaneurol.2024.1552.