StrokeCoRiskNCT00878813
Copeptin for Risk Stratification in Acute Stroke Patients: the CoRisk Study
An observational study of Stroke and Transient Ischemic Attack, run by Insel Gruppe AG, University Hospital Bern at 4 sites in 2 countries.
Trial summary
Prospective observational multicenter study to evaluate copeptin as a prognostic marker in patients with an acute cerebrovascular event. It includes four groups of patients, mainly depending on type of initial therapy (intra-arterial thrombolysis, intravenous thrombolysis, conservative treatment, TIA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- What is being tested?
- Sampling of 15ml blood and Blood-Sampling
- Type of treatment
- Surgery or procedure
- How many people
- 1,102 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2009to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients who are admitted to the emergency department of the Inselspital Bern - Switzerland with a clinical diagnosis of acute ischemic stroke within 24 hours of symptom onset. Inselspital Bern is a university based hospital with a catchment area of about 1.000.000 people
Who may be able to join
- All consecutive patients who are admitted to the emergency department with a clinical diagnosis of cerebrovascular event (TIA, stroke) within 24 hours of symptom onset
Who cannot join
- Patients without informed consent. Patients discharged with a diagnosis different from stroke or TIA after diagnostic evaluation.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany2 sites
Abteilung für Neurologie Charité - Campus Benjamin Franklin
Berlin
Goethe University
Frankfurt am Main
Switzerland2 sites
Neurologische Klinik, Universitätsspital Basel
Basel, 4031
University Clinic for Neurology, Bern University Hospital
Bern, 3010
About this study
Official title: Copeptin for Risk Stratification in Acute Stroke Patients: the CoRisk-study
Prospective observational multicenter study to evaluate copeptin as a prognostic marker in patients with an acute cerebrovascular event. It includes four groups of patients, mainly depending on type of initial therapy (intra-arterial thrombolysis, intravenous thrombolysis, conservative treatment, TIA). The study takes place at the Emergency and neurological Department of the University of Bern, Switzerland; Department of Neurology, Goethe University of Frankfurt a.M. (Germany). Further participating centers are under discussion
Read the detailed description
Background
The investigators in the Prolyse in Acute Cerebral Thromboembolism (PROACT) II study found that intra-arterial thrombolysis (IAT) with prourokinase within 6 hours after onset of symptoms was beneficial in patients with middle cerebral artery (MCA) occlusion. Intra-arterial thrombolysis (IAT) thus is an option for treatment of selected patients who have major stroke of <6 hours' duration due to occlusions of the MCA. Recently observational study showed that IAT was more beneficial than intra-venous thrombolysis (IVT) in the specific group of stroke patients presenting with hyperdense middle cerebral artery sign on CT, even though IAT was started later.
However complications after both reperfusion treatment modalities such as symptomatic intracerebral hemorrhage, malignant brain oedema, re-occlusion, infection, and seizures may occur. Unfortunately few clinical signs provide prognostic information for clear risk stratification. The guidelines for reperfusion therapies in Switzerland, Europe and the US do not include -for the time being- biomarkers in the decision-making-process. However there might be powerful biomarkers, which can serve as point of care tools for the risk stratification of candidates to receive thrombolysis. Plasma copeptin concentration has recently been shown to be an easy to determine, steady parameter which independently predicts functional outcome and death in patients with an acute ischemic stroke. Copeptin derives from a larger precursor peptide (pre-provasopressin) along with two other peptides, Vasopressin (AVP) and neurophysin II. Released in an equimolar ratio, the amount of copeptin mirrors the production of AVP. AVP plays an important role in the regulation of the hypothalamo-pituitary-adrenal (HPA) axis and, thus, reflecting the individual stress response. "Stressors" such as stroke are strong stimulators of the release of AVP. The close and reproducible relation of copeptin levels to the degree of activation of the stress axis is the basis of its usefulness as a biomarker. Early prognostic factors to predict mortality and outcome in stroke patients are important to guide and tailor early decision on treatment. In this context, copeptin may be helpful tool in the early risk stratification of stroke patients to guide the decision for reperfusion therapies.
Objective
To evaluate copeptin as prognostic tool to predict outcome in a well-defined cohort of stroke patients.
Methods
Step 1. All eligible patients in the emergency department or the neurological ward will be evaluated for enrollment into the study. On admission, 2 x 7.5ml- EDTA-blood tubes will be drawn during the first routine blood sampling, and 2 x 7.5ml-EDTA-blood tubes on the following routine blood-sampling. Copeptin levels will be assessed in a blinded batch analysis upon completion of the plasma asservation. Measurement will be performed with a new chemiluminescence sandwich immunoassay.
Step 2. All baseline data will be collected. CT or MRI will be performed 22 to 36 hours after IAT. All complications including death after the reperfusion therapies will be assessed until discharge.
Step 3. A telephone follow-up regarding morbidity and mortality will be obtained after 3 months. An unfavorable outcome will be defined as a mRs of 3 to 6
- Conditions
- Stroke, Transient Ischemic Attack
- Being tested
- Sampling of 15ml blood, Blood-Sampling
- Keywords
- Copeptin, Vasopressin, Stroke, Transient ischemic attack, Thrombolytic therapy, Prognosis, Complications
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of 15ml bloodProcedure or surgery
On admission, 2 x 7.5ml blood tubes will be drawn during the first routine blood sampling
Blood-SamplingProcedure or surgery
On day 1 after intra-arterial thrombolysis, 2 x 7.5ml blood tubes on the following routine blood-sampling will be drawn.
| Study group | Role | What they receive |
|---|---|---|
| 1 | All consecutive stroke patients undergoing acute intra-arterial revascularisation therapy Receives: Procedure: Sampling of 15ml blood; Procedure: Blood-Sampling | |
| 2 | All consecutive stroke patients undergoing acute intra-venous revascularisation therapy Receives: Procedure: Sampling of 15ml blood; Procedure: Blood-Sampling | |
| 3 | All consecutive stroke patients treated conservatively Receives: Procedure: Sampling of 15ml blood | |
| 4 | All consecutive TIA patients Receives: Procedure: Sampling of 15ml blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major disability or death
Measured: 90 days after qualifying event
Secondary outcomes (6)
Symptomatic intracranial hemorrhage
Measured: until hospital discharge
Malignant brain oedema
Measured: until hospital discharge
Aspiration pneumonia
Measured: until hospital discharge
Seizure
Measured: until hospital discharge
Mortality
Measured: until hospital discharge
severe cerebrovascular re-event (i.e. new TIA, and stroke)
Measured: 90 days after qualifying event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, Charite University, Berlin, Germany, Goethe University
- Responsible party
- Sponsor
- Investigators
- Gian Marco De Marchis, MD, Principal investigator, Inselspital, Bern University HospitalMarcel Arnold, MD, Principal investigator, Inselspital, Bern University HospitalMira Katan, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878813
- Sponsor's protocol ID
- KEK 001/09
- Acronym
- CoRisk
- Status last verified
- Nov 2011
- First submitted
- 1 Apr 2009
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. Prolyse in Acute Cerebral Thromboembolism. JAMA. 1999 Dec 1;282(21):2003-11. doi: 10.1001/jama.282.21.2003.
PubMed 10591382Mattle HP, Arnold M, Georgiadis D, Baumann C, Nedeltchev K, Benninger D, Remonda L, von Budingen C, Diana A, Pangalu A, Schroth G, Baumgartner RW. Comparison of intraarterial and intravenous thrombolysis for ischemic stroke with hyperdense middle cerebral artery sign. Stroke. 2008 Feb;39(2):379-83. doi: 10.1161/STROKEAHA.107.492348. Epub 2007 Dec 20.
PubMed 18096842Maramattom BV, Bahn MM, Wijdicks EF. Which patient fares worse after early deterioration due to swelling from hemispheric stroke? Neurology. 2004 Dec 14;63(11):2142-5. doi: 10.1212/01.wnl.0000145626.30318.8a.
PubMed 15596765Aslanyan S, Weir CJ, Diener HC, Kaste M, Lees KR; GAIN International Steering Committee and Investigators. Pneumonia and urinary tract infection after acute ischaemic stroke: a tertiary analysis of the GAIN International trial. Eur J Neurol. 2004 Jan;11(1):49-53. doi: 10.1046/j.1468-1331.2003.00749.x.
PubMed 14692888Warach S, Latour LL. Evidence of reperfusion injury, exacerbated by thrombolytic therapy, in human focal brain ischemia using a novel imaging marker of early blood-brain barrier disruption. Stroke. 2004 Nov;35(11 Suppl 1):2659-61. doi: 10.1161/01.STR.0000144051.32131.09. Epub 2004 Oct 7.
PubMed 15472105Rubiera M, Alvarez-Sabin J, Ribo M, Montaner J, Santamarina E, Arenillas JF, Huertas R, Delgado P, Purroy F, Molina CA. Predictors of early arterial reocclusion after tissue plasminogen activator-induced recanalization in acute ischemic stroke. Stroke. 2005 Jul;36(7):1452-6. doi: 10.1161/01.STR.0000170711.43405.81. Epub 2005 Jun 9.
PubMed 15947260Adams HP Jr, del Zoppo G, Alberts MJ, Bhatt DL, Brass L, Furlan A, Grubb RL, Higashida RT, Jauch EC, Kidwell C, Lyden PD, Morgenstern LB, Qureshi AI, Rosenwasser RH, Scott PA, Wijdicks EF; American Heart Association; American Stroke Association Stroke Council; Clinical Cardiology Council; Cardiovascular Radiology and Intervention Council; Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: the American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Stroke. 2007 May;38(5):1655-711. doi: 10.1161/STROKEAHA.107.181486. Epub 2007 Apr 12.
PubMed 17431204Toni D, Chamorro A, Kaste M, Lees K, Wahlgren NG, Hacke W; EUSI Executive Committee; EUSI Writing Committee. Acute treatment of ischaemic stroke. European Stroke Initiative. Cerebrovasc Dis. 2004;17 Suppl 2:30-46. doi: 10.1159/000074818. No abstract available.
PubMed 14707405Morgenthaler NG, Struck J, Alonso C, Bergmann A. Assay for the measurement of copeptin, a stable peptide derived from the precursor of vasopressin. Clin Chem. 2006 Jan;52(1):112-9. doi: 10.1373/clinchem.2005.060038. Epub 2005 Nov 3.
PubMed 16269513Katan M, Morgenthaler N, Widmer I, Puder JJ, Konig C, Muller B, Christ-Crain M. Copeptin, a stable peptide derived from the vasopressin precursor, correlates with the individual stress level. Neuro Endocrinol Lett. 2008 Jun;29(3):341-6.
PubMed 18580851Rudin S, Kriemler L, Dittrich TD, Zietz A, Schweizer J, Arnold M, Peters N, Barinka F, Jung S, Arnold M, Fischer U, Rentsch K, Christ-Crain M, Katan M, De Marchis GM. Lipoprotein(a) as a blood marker for large artery atherosclerosis stroke etiology: validation in a prospective cohort from a swiss stroke center. Swiss Med Wkly. 2024 Apr 2;154:3633. doi: 10.57187/s.3633.
PubMed 38579294De Marchis GM, Dankowski T, Konig IR, Fladt J, Fluri F, Gensicke H, Foerch C, Findling O, Kurmann R, Fischer U, Luft A, Buhl D, Engelter ST, Lyrer PA, Christ-Crain M, Arnold M, Katan M. A novel biomarker-based prognostic score in acute ischemic stroke: The CoRisk score. Neurology. 2019 Mar 26;92(13):e1517-e1525. doi: 10.1212/WNL.0000000000007177. Epub 2019 Mar 1.
PubMed 30824558De Marchis GM, Weck A, Audebert H, Benik S, Foerch C, Buhl D, Schuetz P, Jung S, Seiler M, Morgenthaler NG, Mattle HP, Mueller B, Christ-Crain M, Arnold M, Katan M. Copeptin for the prediction of recurrent cerebrovascular events after transient ischemic attack: results from the CoRisk study. Stroke. 2014 Oct;45(10):2918-23. doi: 10.1161/STROKEAHA.114.005584. Epub 2014 Aug 28.
PubMed 25169950De Marchis GM, Katan M, Weck A, Brekenfeld C, Mattle HP, Buhl D, Muller B, Christ-Crain M, Arnold M. Copeptin and risk stratification in patients with ischemic stroke and transient ischemic attack: the CoRisk study. Int J Stroke. 2013 Apr;8(3):214-8. doi: 10.1111/j.1747-4949.2011.00762.x. Epub 2012 Feb 15.
PubMed 22336226Katan M, Elkind MS. Inflammatory and neuroendocrine biomarkers of prognosis after ischemic stroke. Expert Rev Neurother. 2011 Feb;11(2):225-39. doi: 10.1586/ern.10.200.
PubMed 21306210
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin for Risk Stratification in Acute Stroke Patients: the CoRisk-study
- ClinicalTrials.gov ID
- NCT00878813
- Acronym / sponsor ID
- CoRisk / KEK 001/09
- Conditions
- Stroke, Transient Ischemic Attack
- Keywords
- Copeptin, Vasopressin, Stroke, Transient ischemic attack, Thrombolytic therapy, Prognosis, Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,102 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Basel, Charite University, Berlin, Germany, Goethe University
- Study start
- Mar 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective observational multicenter study to evaluate copeptin as a prognostic marker in patients with an acute cerebrovascular event. It includes four groups of patients, mainly depending on type of initial therapy (intra-arterial thrombolysis, intravenous thrombolysis, conservative treatment, TIA). The study takes place at the Emergency and neurological Department of the University of Bern, Switzerland; Department of Neurology, Goethe University of Frankfurt a.M. (Germany). Further participating centers are under discussion
Detailed description
Background
The investigators in the Prolyse in Acute Cerebral Thromboembolism (PROACT) II study found that intra-arterial thrombolysis (IAT) with prourokinase within 6 hours after onset of symptoms was beneficial in patients with middle cerebral artery (MCA) occlusion. Intra-arterial thrombolysis (IAT) thus is an option for treatment of selected patients who have major stroke of <6 hours' duration due to occlusions of the MCA. Recently observational study showed that IAT was more beneficial than intra-venous thrombolysis (IVT) in the specific group of stroke patients presenting with hyperdense middle cerebral artery sign on CT, even though IAT was started later.
However complications after both reperfusion treatment modalities such as symptomatic intracerebral hemorrhage, malignant brain oedema, re-occlusion, infection, and seizures may occur. Unfortunately few clinical signs provide prognostic information for clear risk stratification. The guidelines for reperfusion therapies in Switzerland, Europe and the US do not include -for the time being- biomarkers in the decision-making-process. However there might be powerful biomarkers, which can serve as point of care tools for the risk stratification of candidates to receive thrombolysis. Plasma copeptin concentration has recently been shown to be an easy to determine, steady parameter which independently predicts functional outcome and death in patients with an acute ischemic stroke. Copeptin derives from a larger precursor peptide (pre-provasopressin) along with two other peptides, Vasopressin (AVP) and neurophysin II. Released in an equimolar ratio, the amount of copeptin mirrors the production of AVP. AVP plays an important role in the regulation of the hypothalamo-pituitary-adrenal (HPA) axis and, thus, reflecting the individual stress response. "Stressors" such as stroke are strong stimulators of the release of AVP. The close and reproducible relation of copeptin levels to the degree of activation of the stress axis is the basis of its usefulness as a biomarker. Early prognostic factors to predict mortality and outcome in stroke patients are important to guide and tailor early decision on treatment. In this context, copeptin may be helpful tool in the early risk stratification of stroke patients to guide the decision for reperfusion therapies.
Objective
To evaluate copeptin as prognostic tool to predict outcome in a well-defined cohort of stroke patients.
Methods
Step 1. All eligible patients in the emergency department or the neurological ward will be evaluated for enrollment into the study. On admission, 2 x 7.5ml- EDTA-blood tubes will be drawn during the first routine blood sampling, and 2 x 7.5ml-EDTA-blood tubes on the following routine blood-sampling. Copeptin levels will be assessed in a blinded batch analysis upon completion of the plasma asservation. Measurement will be performed with a new chemiluminescence sandwich immunoassay.
Step 2. All baseline data will be collected. CT or MRI will be performed 22 to 36 hours after IAT. All complications including death after the reperfusion therapies will be assessed until discharge.
Step 3. A telephone follow-up regarding morbidity and mortality will be obtained after 3 months. An unfavorable outcome will be defined as a mRs of 3 to 6
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Sampling of 15ml blood, Procedure: Blood-SamplingAll consecutive stroke patients undergoing acute intra-arterial revascularisation therapy |
| 2 | – | Procedure: Sampling of 15ml blood, Procedure: Blood-SamplingAll consecutive stroke patients undergoing acute intra-venous revascularisation therapy |
| 3 | – | Procedure: Sampling of 15ml bloodAll consecutive stroke patients treated conservatively |
| 4 | – | Procedure: Sampling of 15ml bloodAll consecutive TIA patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients who are admitted to the emergency department of the Inselspital Bern - Switzerland with a clinical diagnosis of acute ischemic stroke within 24 hours of symptom onset. Inselspital Bern is a university based hospital with a catchment area of about 1.000.000 people
Key inclusion criteria (1 listed)
- All consecutive patients who are admitted to the emergency department with a clinical diagnosis of cerebrovascular event (TIA, stroke) within 24 hours of symptom onset
Key exclusion criteria (1 listed)
- Patients without informed consent. Patients discharged with a diagnosis different from stroke or TIA after diagnostic evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling of 15ml bloodOn admission, 2 x 7.5ml blood tubes will be drawn during the first routine blood sampling | Procedure or surgery | 1, 2, 3, 4 |
| Blood-SamplingOn day 1 after intra-arterial thrombolysis, 2 x 7.5ml blood tubes on the following routine blood-sampling will be drawn. | Procedure or surgery | 1, 2 |
Primary outcome
Major disability or death
Time frame: 90 days after qualifying event
6 secondary outcomes
Symptomatic intracranial hemorrhage
Time frame: until hospital discharge
Malignant brain oedema
Time frame: until hospital discharge
Aspiration pneumonia
Time frame: until hospital discharge
Seizure
Time frame: until hospital discharge
Mortality
Time frame: until hospital discharge
severe cerebrovascular re-event (i.e. new TIA, and stroke)
Time frame: 90 days after qualifying event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
- Background: PubMed 10591382Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. Prolyse in Acute Cerebral Thromboembolism. JAMA. 1999 Dec 1;282(21):2003-11. doi: 10.1001/jama.282.21.2003.
- Background: PubMed 18096842Mattle HP, Arnold M, Georgiadis D, Baumann C, Nedeltchev K, Benninger D, Remonda L, von Budingen C, Diana A, Pangalu A, Schroth G, Baumgartner RW. Comparison of intraarterial and intravenous thrombolysis for ischemic stroke with hyperdense middle cerebral artery sign. Stroke. 2008 Feb;39(2):379-83. doi: 10.1161/STROKEAHA.107.492348. Epub 2007 Dec 20.
- Background: PubMed 15596765Maramattom BV, Bahn MM, Wijdicks EF. Which patient fares worse after early deterioration due to swelling from hemispheric stroke? Neurology. 2004 Dec 14;63(11):2142-5. doi: 10.1212/01.wnl.0000145626.30318.8a.
- Background: PubMed 14692888Aslanyan S, Weir CJ, Diener HC, Kaste M, Lees KR; GAIN International Steering Committee and Investigators. Pneumonia and urinary tract infection after acute ischaemic stroke: a tertiary analysis of the GAIN International trial. Eur J Neurol. 2004 Jan;11(1):49-53. doi: 10.1046/j.1468-1331.2003.00749.x.
- Background: PubMed 15472105Warach S, Latour LL. Evidence of reperfusion injury, exacerbated by thrombolytic therapy, in human focal brain ischemia using a novel imaging marker of early blood-brain barrier disruption. Stroke. 2004 Nov;35(11 Suppl 1):2659-61. doi: 10.1161/01.STR.0000144051.32131.09. Epub 2004 Oct 7.
- Background: PubMed 15947260Rubiera M, Alvarez-Sabin J, Ribo M, Montaner J, Santamarina E, Arenillas JF, Huertas R, Delgado P, Purroy F, Molina CA. Predictors of early arterial reocclusion after tissue plasminogen activator-induced recanalization in acute ischemic stroke. Stroke. 2005 Jul;36(7):1452-6. doi: 10.1161/01.STR.0000170711.43405.81. Epub 2005 Jun 9.
- Background: PubMed 17431204Adams HP Jr, del Zoppo G, Alberts MJ, Bhatt DL, Brass L, Furlan A, Grubb RL, Higashida RT, Jauch EC, Kidwell C, Lyden PD, Morgenstern LB, Qureshi AI, Rosenwasser RH, Scott PA, Wijdicks EF; American Heart Association; American Stroke Association Stroke Council; Clinical Cardiology Council; Cardiovascular Radiology and Intervention Council; Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: the American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Stroke. 2007 May;38(5):1655-711. doi: 10.1161/STROKEAHA.107.181486. Epub 2007 Apr 12.
- Background: PubMed 14707405Toni D, Chamorro A, Kaste M, Lees K, Wahlgren NG, Hacke W; EUSI Executive Committee; EUSI Writing Committee. Acute treatment of ischaemic stroke. European Stroke Initiative. Cerebrovasc Dis. 2004;17 Suppl 2:30-46. doi: 10.1159/000074818. No abstract available.
- Background: PubMed 16269513Morgenthaler NG, Struck J, Alonso C, Bergmann A. Assay for the measurement of copeptin, a stable peptide derived from the precursor of vasopressin. Clin Chem. 2006 Jan;52(1):112-9. doi: 10.1373/clinchem.2005.060038. Epub 2005 Nov 3.
- Background: PubMed 18580851Katan M, Morgenthaler N, Widmer I, Puder JJ, Konig C, Muller B, Christ-Crain M. Copeptin, a stable peptide derived from the vasopressin precursor, correlates with the individual stress level. Neuro Endocrinol Lett. 2008 Jun;29(3):341-6.
- Derived from this study: PubMed 38579294Rudin S, Kriemler L, Dittrich TD, Zietz A, Schweizer J, Arnold M, Peters N, Barinka F, Jung S, Arnold M, Fischer U, Rentsch K, Christ-Crain M, Katan M, De Marchis GM. Lipoprotein(a) as a blood marker for large artery atherosclerosis stroke etiology: validation in a prospective cohort from a swiss stroke center. Swiss Med Wkly. 2024 Apr 2;154:3633. doi: 10.57187/s.3633.
- Derived from this study: PubMed 30824558De Marchis GM, Dankowski T, Konig IR, Fladt J, Fluri F, Gensicke H, Foerch C, Findling O, Kurmann R, Fischer U, Luft A, Buhl D, Engelter ST, Lyrer PA, Christ-Crain M, Arnold M, Katan M. A novel biomarker-based prognostic score in acute ischemic stroke: The CoRisk score. Neurology. 2019 Mar 26;92(13):e1517-e1525. doi: 10.1212/WNL.0000000000007177. Epub 2019 Mar 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gian Marco De Marchis, MD principal investigator
Inselspital, Bern University Hospital
Marcel Arnold, MD principal investigator
Inselspital, Bern University Hospital
Mira Katan, MD principal investigator
University Hospital, Basel, Switzerland
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Transient Ischemic Attack, run by Insel Gruppe AG, University Hospital Bern at 4 sites in 2 countries.
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 1 inclusion and 1 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 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Major disability or death (time frame: 90 days after qualifying event). 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 NCT00878813, which also lists 15 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 10 Nov 2011.