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Stroke, IschemicPRAISENCT03609385

PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE

An observational study of Stroke, Ischemic and Acute Coronary Syndrome, run by Charite University, Berlin, Germany at 28 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Ischemic, Acute Coronary Syndrome
What is being tested?
Coronary angiography
How many people
254 participants
Where
28 sitesGermany
Study dates
1 Aug 2018to 26 Sep 2022
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Germany28 sites

  • Rhön-Klinikum Campus Bad Neustadt

    Bad Neustadt an der Saale

  • Charité-Campus Mitte

    Berlin, 10117

  • Charité-Campus Benjamin Franklin

    Berlin, 12203

  • Charité-Campus Virchow Klinikum

    Berlin, 13353

  • Jüdisches Krankenhaus

    Berlin

  • Universitätsklinikum Bonn

    Bonn

  • Allgemeines Krankenhaus Celle

    Celle

  • Universitätsklinikum Dresden

    Dresden

  • Universitätsklinikum Erlangen

    Erlangen

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Klinikum Friedrichshafen

    Friedrichshafen

  • Klinikum Fulda

    Fulda

  • Universitätsmedizin Göttingen

    Göttingen

  • Universitätsklinikum Greifswald

    Greifswald

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Universitätsklinikum Heidelberg

    Heidelberg

  • Universitätsklinikum Jena

    Jena

  • Universitätsklinikum Leipzig

    Leipzig

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck

  • Universitätsklinikum Magdeburg

    Magdeburg

  • Universitätsklinikum Mannheim

    Mannheim

  • Technische Universität München (TUM)

    München

  • Universitätsklinikum der Ludwig-Maximilians-Universität München

    Munich

  • Klinikum Nürnberg Süd

    Nuremberg

  • Klinikum Osnabrück

    Osnabrück

  • Universitätsmedizin Rostock

    Rostock

  • Universitätsklinikum Tübingen

    Tübingen

  • Universitätsklinikum Ulm

    Ulm

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Coronary angiography
Keywords
stroke, troponin, acute coronary syndrome, culprit lesion
Medical subject headings
Ischemic Stroke, Acute Coronary Syndrome, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary angiographyDiagnostic test

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

Study groups in NCT03609385
Study groupRoleWhat they receive
Stroke patients with elevated troponinPatients 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
Receives: Diagnostic Test: Coronary angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of Myocardial Infarction

    the diagnosis will be established by an independent endpoint committee

    Measured: within seven days of admission to hospital

Secondary outcomes (3)

  1. Mortality

    mortality will be recorded during the stay in hospital as well as after three and twelve months

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

  2. Functional Outcome

    functional outcome will be evaluated using the modified Rankin scale (0-6 with greater scores indicating poorer functional outcome)

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

  3. Cardiovascular Events

    cardiovascular events include new stroke, transient ischemic attack and myocardial infarction and mortality

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2018
  2. Study start1 Aug 2018
  3. Primary completion20 Dec 2021
  4. Study completion26 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03609385
Sponsor's protocol ID
EA1/057/18
Acronym
PRAISE
Status last verified
Mar 2025
First submitted
6 Jul 2018
Last updated
26 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32854663

  • 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.

    PubMed 38829625

  • 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.

    PubMed 41189028

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, Ischemic and Acute Coronary Syndrome, run by Charite University, Berlin, Germany at 28 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of Myocardial Infarction (time frame: within seven days of admission to hospital). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03609385, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

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