PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE

NCT ID: NCT03609385

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 254 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2022-09-26

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.

Conditions

Stroke, Ischemic; Acute Coronary Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stroke patients with elevated troponin

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

Coronary angiography

Intervention Type: DIAGNOSTIC_TEST

In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.

Interventions

Coronary angiography

In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

Sponsor Role: collaborator

German Center for Neurodegenerative Diseases (DZNE)

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Matthias Endres

Prof Dr med. Matthias Endres

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthias Endres, Prof

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Ulf Landmesser, Prof

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Christian Nolte, Prof

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Rhön-Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, , Germany

Charité-Campus Mitte

Berlin, , Germany

Charité-Campus Benjamin Franklin

Berlin, , Germany

Charité-Campus Virchow Klinikum

Berlin, , Germany

Jüdisches Krankenhaus

Berlin, , Germany

Universitätsklinikum Bonn

Bonn, , Germany

Allgemeines Krankenhaus Celle

Celle, , Germany

Universitätsklinikum Dresden

Dresden, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Klinikum Friedrichshafen

Friedrichshafen, , Germany

Klinikum Fulda

Fulda, , Germany

Universitätsmedizin Göttingen

Göttingen, , Germany

Universitätsklinikum Greifswald

Greifswald, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Universitätsklinikum Jena

Jena, , Germany

Universitätsklinikum Leipzig

Leipzig, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Universitätsklinikum Magdeburg

Magdeburg, , Germany

Universitätsklinikum Mannheim

Mannheim, , Germany

Universitätsklinikum der Ludwig-Maximilians-Universität München

Munich, , Germany

Technische Universität München (TUM)

München, , Germany

Klinikum Nürnberg Süd

Nuremberg, , Germany

Klinikum Osnabrück

Osnabrück, , Germany

Universitätsmedizin Rostock

Rostock, , Germany

Universitätsklinikum Tübingen

Tübingen, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 32854663 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38829625 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

EA1/057/18

Identifier Type: -

Identifier Source: org_study_id