PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE

NCT03609385 | Completed Results DMC

• 1 other identifier: EA1/057/18
• Study Type: observational
• Target: 254
• Locations: 1 country
• Sites: 28

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.

Conditions

Stroke, Ischemic; Acute Coronary Syndrome

Keywords

stroke; troponin; acute coronary syndrome; culprit lesion

Outcome Measures

Primary Outcomes (1)

• Presence of Myocardial Infarction

  the diagnosis will be established by an independent endpoint committee

  within seven days of admission to hospital

Secondary Outcomes (3)

• Mortality

  at one week and at three and twelve months after the initial event, at 12 months reported.

• Functional Outcome

  at baseline, at one week and at three and twelve months after the initial event, 12 months reported

• Cardiovascular Events

  at one week and at three and twelve months after the initial event, 12 months reported

Study Arms (1)

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

Diagnostic Test: Coronary angiography

Interventions

Coronary angiography DIAGNOSTIC_TEST

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

Stroke patients with elevated troponin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

consecutive patients with acute ischemic stroke admitted to the participating sites will be systematically screened for eligibility

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator
• German Center for Neurodegenerative Diseases (DZNE): collaborator

Study Sites (28)

Rhön-Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, Germany

Location

Charité-Campus Mitte

Berlin, 10117, Germany

Location

Charité-Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Charité-Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Jüdisches Krankenhaus

Berlin, Germany

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Allgemeines Krankenhaus Celle

Celle, Germany

Location

Universitätsklinikum Dresden

Dresden, Germany

Location

Universitätsklinikum Erlangen

Erlangen, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

Klinikum Friedrichshafen

Friedrichshafen, Germany

Location

Klinikum Fulda

Fulda, Germany

Location

Universitätsmedizin Göttingen

Göttingen, Germany

Location

Universitätsklinikum Greifswald

Greifswald, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Universitätsklinikum Jena

Jena, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, Germany

Location

Universitätsklinikum Magdeburg

Magdeburg, Germany

Location

Universitätsklinikum Mannheim

Mannheim, Germany

Location

Universitätsklinikum der Ludwig-Maximilians-Universität München

Munich, Germany

Location

Technische Universität München (TUM)

München, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, Germany

Location

Klinikum Osnabrück

Osnabrück, Germany

Location

Universitätsmedizin Rostock

Rostock, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Related Publications (3)

• 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.

  PMID: 32854663 BACKGROUND

• 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.

  PMID: 38829625 RESULT

• von Rennenberg R, Litmeier S, Szabo K, Mengel A, Petersen M, Wunderlich S, Michalski D, Thomalla G, Kallmunzer B, Petzold G, Dichgans M, Siepmann T, Royl G, Ringleb PA, Nolte CH, Endres M. Cognitive performance in patients with ischemic stroke and additional myocardial injury - results from the multicenter prospective observational PRAISE study. Neurol Res Pract. 2025 Nov 4;7(1):84. doi: 10.1186/s42466-025-00446-4.

  PMID: 41189028 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Acute Coronary Syndrome; Stroke

Interventions

Coronary Angiography

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Heart Function Tests

Results Point of Contact

• Title: Dr. Christian Nolte
• Organization: Charité-Universitätsmedizin Berlin

christian.nolte@charite.de

+4930450560676

Study Officials

• Matthias Endres, Prof

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Ulf Landmesser, Prof

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Christian Nolte, Prof

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr med. Matthias Endres

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: August 1, 2018
• Study Start: August 1, 2018
• Primary Completion: December 20, 2021
• Study Completion: September 26, 2022
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (28)