PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE (PRAISE)

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Stroke, Ischemic
• Intervention / Treatment: Diagnostic test: Coronary angiography

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.

• Study Type: Observational
• Enrollment (Actual): 254

Contacts and Locations

Study Locations

• Germany
  • Bad Neustadt An Der Saale, Germany
    • Rhön-Klinikum Campus Bad Neustadt
  • Berlin, Germany, 10117
    • Charité-Campus Mitte
  • Berlin, Germany, 12203
    • Charitè-Campus Benjamin Franklin
  • Berlin, Germany, 13353
    • Charité-Campus Virchow Klinikum
  • Berlin, Germany
    • Jüdisches Krankenhaus
  • Bonn, Germany
    • Universitätsklinikum Bonn
  • Celle, Germany
    • Allgemeines Krankenhaus Celle
  • Dresden, Germany
    • Universitätsklinikum Dresden
  • Erlangen, Germany
    • Universitätsklinikum Erlangen
  • Frankfurt, Germany
    • Universitätsklinikum Frankfurt
  • Friedrichshafen, Germany
    • Klinikum Friedrichshafen
  • Fulda, Germany
    • Klinikum Fulda
  • Greifswald, Germany
    • Universitätsklinikum Greifswald
  • Göttingen, Germany
    • Universitätsmedizin Göttingen
  • Hamburg, Germany
    • Universitatsklinikum Hamburg-Eppendorf
  • Heidelberg, Germany
    • Universitätsklinikum Heidelberg
  • Jena, Germany
    • Universitätsklinikum Jena
  • Leipzig, Germany
    • Universitätsklinikum Leipzig
  • Lübeck, Germany
    • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Magdeburg, Germany
    • Universitätsklinikum Magdeburg
  • Mannheim, Germany
    • Universitätsklinikum Mannheim
  • Munich, Germany
    • Universitätsklinikum der Ludwig-Maximilians-Universität München
  • München, Germany
    • Technische Universität München (TUM)
  • Nürnberg, Germany
    • Klinikum Nurnberg Sud
  • Osnabrück, Germany
    • Klinikum Osnabrück
  • Rostock, Germany
    • Universitätsmedizin Rostock
  • Tübingen, Germany
    • Universitatsklinikum Tubingen
  • Ulm, Germany
    • Universitatsklinikum Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Myocardial Infarction	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, at 12 months reported.
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, 12 months reported
Cardiovascular Events	cardiovascular events include new stroke, transient ischemic attack and myocardial infarction and mortality	at one week and at three and twelve months after the initial event, 12 months reported

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: German Center for Neurodegenerative Diseases (DZNE); Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): September 26, 2022

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: stroke; acute coronary syndrome; culprit lesion; troponin
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease; Myocardial Ischemia; Ischemic Stroke; Stroke; Syndrome; Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: EA1/057/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No