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Trial record 5 of 89 for:    PRAISE

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

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ClinicalTrials.gov Identifier: NCT03609385
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborators:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
German Center for Neurodegenerative Diseases (DZNE)
Information provided by (Responsible Party):
Matthias Endres, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment
Stroke, Ischemic Acute Coronary Syndrome 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 15 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.


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Study Type : Observational
Estimated Enrollment : 251 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

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.




Primary Outcome Measures :
  1. presence of acute coronary syndrome [ Time Frame: within seven days of admission to hospital ]
    the diagnosis will be established by an independent endpoint committee


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. cognitive outcome during inpatient stay [ Time Frame: at baseline and at one week after the initial event ]
    cognitive outcome will be evaluated using the Montreal Cognitive Assessment

  4. cognitive outcome at follow-up [ Time Frame: at three and twelve months after the initial event ]
    cognitive outcome will be evaluated using the Telephone Interview for Cognitive Status.

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609385


Contacts
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Contact: Regina von Rennenberg +493084454285 regina-irene.freiin-von-rennenberg@charite.de

Locations
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Germany
Charité-Campus Mitte Recruiting
Berlin, Germany, 10117
Contact: Regina von Rennenberg    +493084454285    praise-study@charite.de   
Principal Investigator: Matthias Endres, Prof         
Principal Investigator: Karl Stangl, Prof         
Charité-Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Regina von Rennenberg    +493084454285    praise-study@charite.de   
Principal Investigator: Christian Nolte, Prof         
Principal Investigator: Ulf Landmesser, Prof         
Charité-Campus Virchow Klinikum Recruiting
Berlin, Germany, 13353
Contact: Regina von Rennenberg    +493084454285    praise-study@charite.de   
Principal Investigator: Matthias Endres, Prof         
Principal Investigator: Burkert Pieske, Prof         
Universitätsklinikum Bonn Recruiting
Bonn, Germany
Contact: Gabor Petzold, Prof         
Principal Investigator: Gabor Petzold, Prof         
Principal Investigator: Georg Nickenig, Prof         
Universitätsklinikum Dresden Not yet recruiting
Dresden, Germany
Contact: Volker Pütz, Prof         
Principal Investigator: Volker Pütz, Prof         
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany
Contact: Bernd Kallmünzer, PD Dr         
Principal Investigator: Bernd Kallmünzer, PD Dr         
Universitätsklinikum Essen Not yet recruiting
Essen, Germany
Contact: Martin Köhrmann, Prof         
Principal Investigator: Tienush Rassaf, Prof         
Principal Investigator: Christoph Kleinschnitz, Prof         
Universitätsklinikum Frankfurt Not yet recruiting
Frankfurt, Germany
Contact: Waltraud Pfeilschifter, Prof         
Principal Investigator: Waltraud Pfeilschifter, Prof         
Principal Investigator: Zeiher Andreas, Prof         
Universitätsklinikum Greifswald Not yet recruiting
Greifswald, Germany
Contact: Bettina von Sarnowski, Dr         
Principal Investigator: Agnes Flöel, Prof         
Principal Investigator: Stephan Felix, Prof         
Universitätsmedizin Göttingen Not yet recruiting
Göttingen, Germany
Contact: Jan Liman, PD Dr         
Principal Investigator: Jan Liman, PD Dr         
Principal Investigator: Claudius Jacobshagen, Prof         
Universitätsklinikum Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany
Contact: Götz Thomalla, Prof         
Principal Investigator: Götz Thomalla, Prof         
Principal Investigator: Stefan Blankenberg, Prof         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany
Contact: Peter Ringleb, Prof         
Principal Investigator: Peter Ringleb, Prof         
Principal Investigator: Hugo Katus, Prof         
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany
Contact: Dominik Michalski, Prof         
Principal Investigator: Ulrich Laufs, Prof         
Principal Investigator: Dominik Michalski, Prof         
Universitätsklinikum Schleswig-Holstein, Campus Lübeck Recruiting
Lübeck, Germany
Contact: Georg Royl, PD Dr         
Principal Investigator: Georg Royl, PD Dr         
Principal Investigator: Ingo Eitel, Prof         
Universitätsklinikum der Ludwig-Maximilians-Universität München Recruiting
Munich, Germany
Contact: Stefan Kääb, Prof         
Principal Investigator: Martin Dichgans, Prof         
Principal Investigator: Stefan Kääb, Prof         
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany
Contact: Annerose Mengel, Dr         
Principal Investigator: Annerose Mengel, Dr         
Sponsors and Collaborators
Charite University, Berlin, Germany
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
German Center for Neurodegenerative Diseases (DZNE)
Investigators
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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

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Responsible Party: Matthias Endres, Prof Dr med. Matthias Endres, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03609385     History of Changes
Other Study ID Numbers: EA1/057/18
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthias Endres, Charite University, Berlin, Germany:
stroke
troponin
acute coronary syndrome
culprit lesion
Additional relevant MeSH terms:
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Stroke
Acute Coronary Syndrome
Syndrome
Ischemia
Disease
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases