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

January 10, 2023 updated by: Matthias Endres, Charite University, Berlin, Germany
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

Intervention / Treatment

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)

251

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Judisches 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
        • Universitatsklinikum 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 Nürnberg Süd
      • Osnabrück, Germany
        • Klinikum Osnabruck
      • Rostock, Germany
        • Universitätsmedizin Rostock
      • Tübingen, Germany
        • Universitätsklinikum Tübingen
      • Ulm, Germany
        • Universitätsklinikum Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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 acute coronary syndrome
Time Frame: within seven days of admission to hospital
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
Time Frame: at one week and at three and twelve months after the initial event
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
functional outcome
Time Frame: at baseline, at one week and at three and twelve months after the initial event
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
cardiovascular events
Time Frame: at one week and at three and twelve months after the initial event
cardiovascular events include new stroke, transient ischemic attack and myocardial infarction
at one week and at three and twelve months after the initial event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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