Stroke, IschemicCORONA-ISNCT03892226
Cardiomyocyte Injury Following Acute Ischemic Stroke
An observational study of Stroke, Ischemic and Cardiac Complication, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The primary goal of the CORONA-IS study is to characterize stroke-associated acute myocardial injury (elevated hs-cardiac troponin) using different diagnostic examinations in order get a better understanding of it's underlying pathomechanisms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Cardiac Complication
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2019to Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients with acute ischemic stroke admitted to the hospital's stroke unit will be systematically screened for eligibility
Who may be able to join
- age over 18
- diagnosis of acute ischemic stroke and hospital admission within 48h after onset of the symptoms
- diagnosis based on visible DWI-lesion in MRI
- written informed consent by participant
- repeated measurement of high sensitive Troponin T within 24h of admission (hs-troponin T, Roche Elecsys®, 99. percentile, upper reference limit=14ng/l)
Who cannot join
- Pregnancy and / or breast-feeding.
- Impaired renal function (eGFR < 30 ml/min/1,73 m^2)
- Contraindications to undergo MRI (i.e., mechanic heart valve, cardiac pacemaker, etc.)
- Persistent or permanent atrial fibrillation
- ST- elevation myocardial infarction
- History of coronary artery bypass surgery or percutaneous trans-luminal coronary angioplasty (PTCA) ≤ four weeks
Trial locations and contacts
1 site in 1 country.
About this study
The primary goal of the CORONA-IS study is to characterize stroke-associated acute myocardial injury (elevated hs-cardiac troponin) using different diagnostic examinations in order get a better understanding of it's underlying pathomechanisms.
Read the detailed description
Myocardial injury (i.e. elevated cardiac troponin levels) is a frequent cardiac complication during the first few days after an ischemic stroke and is associated with a poor functional outcome. Myocardial injury represents one essential part of a broad spectrum of cardiac complications ranging to severe arrhythmia or heart failure. There is evidence that, in the majority of patients, the underlying mechanism of stroke-associated myocardial injury is not coronary-mediated myocardial ischemia but rather stroke-induced functional and structural interference in the central autonomic network. The investigators hypothesize that this causes a dysregulation of normal neuronal cardiac control leading to myocardial edema and stunning ('Stroke-Heart-Syndrome') CORONA-IS is a prospective, observational, single-centered cohort study that will recruit 300 patients with acute ischemic stroke. According to serial high sensitivity cTn levels during the first 24h after admission, patients will be assigned to three groups (no myocardial injury, chronic myocardial injury, acute myocardial injury). Study procedures include cardiovascular MRI and transthoracic echocardiography to visualize (transient) cardiac dysfunction and provide detailed tissue characterization, 20-minute Holter-monitoring with an analysis of specific autonomic markers, and a systematic bio-banking to study further mechanisms such as altered microRNA signatures. A follow-up for cardiovascular events will be conducted one year after enrolment to study long-term effects of stoke-associated myocardial injury.
The aim of the CORONA-IS study is to develop a better understanding of the characteristics and the pathophysiology of stroke-induced acute myocardial injury ('Stroke-Heart-Syndrome') in order to identify patients at risk and improve diagnostic and therapeutic procedures.
- Conditions
- Stroke, Ischemic, Cardiac Complication
- Keywords
- stroke, stroke-heart syndrome, troponin, myocardial stunning, acute coronary syndrome, periodic repolarization dynamics, cardiac complications
- Medical subject headings
- Ischemic Stroke, Stroke, Myocardial Stunning, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1, no myocardial injury | normal troponin level (hs-troponin T ≤ 99. percentile, i.e. 14ng/ml) | |
| 2, chronic myocardial injury | elevated, but stable troponin level; (hs-troponin T> 99. percentile and rise/fall ≤ 20% in the control) | |
| 3, acute myocardial injury | dynamic troponin elevation; (hs-troponin T> 99. percentile and rise/fall >20% in the control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of myocardial edema without late gadolinium enhancement (native T1, T2 mapping)
diagnosed in cardiovascular MRI (CMR), conducted at the fourth/fifth day after onset of the ischemic stroke
Measured: within five days of admission to hospital
Rate of myocardial fibrosis with late Gadolinium enhancement (LGE) and acute edema in CMR
Rate of myocardial fibrosis with LGE and acute edema in CMR, suggesting a recent myocardial infarction (<1 month). CMR conducted at the fourth/fifth day after onset of the ischemic stroke.
Measured: within five days of admission to hospital
Rate of signs of left ventricular dysfunction in the CMR
Rate of signs of left ventricular dysfunction in the cardiac MRI (i.e. reduced ejection fraction, end diastolic left ventricular volume, longitudinal strain rate). CMR conducted at the fourth/fifth day after onset of the ischemic stroke.
Measured: within five days of admission to hospital
Rate of acute disturbance of microcirculation
Rate of acute disturbance of microcirculation (measurement on the basis of oxygen extraction in cardiac MRI). CMR conducted at the fourth/fifth day after onset of the ischemic stroke.
Measured: within five days of admission to hospital
Rate of impaired left ventricular function and transient impaired left ventricular function in transthoracic echocardiography
Rate of impaired left ventricular function (ejection fraction <50%, reduced global longitudinal strain etc.) in the transthoracic echocardiography as well as higher rate of transient left ventricular dysfunction detected in repeated transthoracic echocardiography (TTE). The TTE will be conducted at the first day after enrolment as well as at the day before discharge or five days after the first TTE respectively.
Measured: within seven days of admission to hospital
Secondary outcomes (5)
Rate of pathologic Periodic Repolarization Dynamics (PRDs) and Deceleration Capacity (DC)
Rate of Periodic Repolarization Dynamics (PRDs) and Deceleration Capacity (DC) in the 20 minutes Holter ECG as sign of enhanced sympathetic activity (PRD> 5.75 deg^2, DC ≤2.5 ms).
Measured: within seven days of admission to hospital
Difference in specific microRNA pattern in participants with myocardial damage induced by acute ischemic stroke
Analysis of circulating microRNA pattern via next generation Sequencing in patient's blood samples.
Measured: within seven days of admission to hospital
Mortality
mortality (rate of deaths) will be recorded during the stay in hospital as well as after twelve months
Measured: at one week and twelve months after the initial event
Functional outcome
functional outcome will be evaluated using the 'modified Rankin scale' (range from 0 = no symptoms to 6 = death; favorable outcome defined as 0 or 1 in the modified Rankin scale)
Measured: at baseline, at seven days after baseline (or at day of discharge from hospital if <7d, respectively) and at twelve months after the initial event
Rate of cardiovascular events
cardiovascular events include new stroke, transient ischemic attack and myocardial infarction
Measured: at one week and at twelve months after the initial event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Apr 2019
- Primary completion31 Dec 2023
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Jan Friedrich Scheitz, Charite University, Berlin, Germany
- Investigators
- Jan Scheitz, PD Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892226
- Sponsor's protocol ID
- EA4/123/18
- Acronym
- CORONA-IS
- Status last verified
- Feb 2024
- First submitted
- 25 Mar 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scheitz JF, Nolte CH, Doehner W, Hachinski V, Endres M. Stroke-heart syndrome: clinical presentation and underlying mechanisms. Lancet Neurol. 2018 Dec;17(12):1109-1120. doi: 10.1016/S1474-4422(18)30336-3. Epub 2018 Oct 26.
PubMed 30509695Mochmann HC, Scheitz JF, Petzold GC, Haeusler KG, Audebert HJ, Laufs U, Schneider C, Landmesser U, Werner N, Endres M, Witzenbichler B, Nolte CH; TRELAS Study Group. Coronary Angiographic Findings in Acute Ischemic Stroke Patients With Elevated Cardiac Troponin: The Troponin Elevation in Acute Ischemic Stroke (TRELAS) Study. Circulation. 2016 Mar 29;133(13):1264-71. doi: 10.1161/CIRCULATIONAHA.115.018547. Epub 2016 Mar 1.
PubMed 26933082Rizas KD, Hamm W, Kaab S, Schmidt G, Bauer A. Periodic Repolarisation Dynamics: A Natural Probe of the Ventricular Response to Sympathetic Activation. Arrhythm Electrophysiol Rev. 2016 May;5(1):31-6. doi: 10.15420/aer.2015:30:2.
PubMed 27403291Stengl H, Ganeshan R, Hellwig S, Blaszczyk E, Fiebach JB, Nolte CH, Bauer A, Schulz-Menger J, Endres M, Scheitz JF. Cardiomyocyte Injury Following Acute Ischemic Stroke: Protocol for a Prospective Observational Cohort Study. JMIR Res Protoc. 2021 Feb 5;10(2):e24186. doi: 10.2196/24186.
PubMed 33544087Scheitz JF, Stengl H, Nolte CH, Landmesser U, Endres M. Neurological update: use of cardiac troponin in patients with stroke. J Neurol. 2021 Jun;268(6):2284-2292. doi: 10.1007/s00415-020-10349-w. Epub 2020 Dec 29.
PubMed 33372247Rosso M, Stengl H, Ganeshan R, Hellwig S, Klammer MG, von Rennenberg R, Bohme S, Nolte CH, Audebert HJ, Endres M, Kasner SE, Scheitz JF. Sex Differences in Outcomes of Acute Myocardial Injury After Stroke. J Am Heart Assoc. 2024 Mar 5;13(5):e032755. doi: 10.1161/JAHA.123.032755. Epub 2024 Feb 27.
PubMed 38410952
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiomyocyte Injury Following Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03892226
- Acronym / sponsor ID
- CORONA-IS / EA4/123/18
- Conditions
- Stroke, Ischemic, Cardiac Complication
- Keywords
- stroke, stroke-heart syndrome, troponin, myocardial stunning, acute coronary syndrome, periodic repolarization dynamics, cardiac complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Mar 2019 (actual)
- 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.
The primary goal of the CORONA-IS study is to characterize stroke-associated acute myocardial injury (elevated hs-cardiac troponin) using different diagnostic examinations in order get a better understanding of it's underlying pathomechanisms.
Detailed description
Myocardial injury (i.e. elevated cardiac troponin levels) is a frequent cardiac complication during the first few days after an ischemic stroke and is associated with a poor functional outcome. Myocardial injury represents one essential part of a broad spectrum of cardiac complications ranging to severe arrhythmia or heart failure. There is evidence that, in the majority of patients, the underlying mechanism of stroke-associated myocardial injury is not coronary-mediated myocardial ischemia but rather stroke-induced functional and structural interference in the central autonomic network. The investigators hypothesize that this causes a dysregulation of normal neuronal cardiac control leading to myocardial edema and stunning ('Stroke-Heart-Syndrome') CORONA-IS is a prospective, observational, single-centered cohort study that will recruit 300 patients with acute ischemic stroke. According to serial high sensitivity cTn levels during the first 24h after admission, patients will be assigned to three groups (no myocardial injury, chronic myocardial injury, acute myocardial injury). Study procedures include cardiovascular MRI and transthoracic echocardiography to visualize (transient) cardiac dysfunction and provide detailed tissue characterization, 20-minute Holter-monitoring with an analysis of specific autonomic markers, and a systematic bio-banking to study further mechanisms such as altered microRNA signatures. A follow-up for cardiovascular events will be conducted one year after enrolment to study long-term effects of stoke-associated myocardial injury.
The aim of the CORONA-IS study is to develop a better understanding of the characteristics and the pathophysiology of stroke-induced acute myocardial injury ('Stroke-Heart-Syndrome') in order to identify patients at risk and improve diagnostic and therapeutic procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1, no myocardial injury | – | –normal troponin level (hs-troponin T ≤ 99. percentile, i.e. 14ng/ml) |
| 2, chronic myocardial injury | – | –elevated, but stable troponin level; (hs-troponin T> 99. percentile and rise/fall ≤ 20% in the control) |
| 3, acute myocardial injury | – | –dynamic troponin elevation; (hs-troponin T> 99. percentile and rise/fall >20% in the control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients with acute ischemic stroke admitted to the hospital's stroke unit will be systematically screened for eligibility
Key inclusion criteria (5 listed)
- age over 18
- diagnosis of acute ischemic stroke and hospital admission within 48h after onset of the symptoms
- diagnosis based on visible DWI-lesion in MRI
- written informed consent by participant
- repeated measurement of high sensitive Troponin T within 24h of admission (hs-troponin T, Roche Elecsys®, 99. percentile, upper reference limit=14ng/l)
Key exclusion criteria (6 listed)
- Pregnancy and / or breast-feeding.
- Impaired renal function (eGFR < 30 ml/min/1,73 m^2)
- Contraindications to undergo MRI (i.e., mechanic heart valve, cardiac pacemaker, etc.)
- Persistent or permanent atrial fibrillation
- ST- elevation myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of myocardial edema without late gadolinium enhancement (native T1, T2 mapping)
Time frame: within five days of admission to hospital
diagnosed in cardiovascular MRI (CMR), conducted at the fourth/fifth day after onset of the ischemic stroke
Rate of myocardial fibrosis with late Gadolinium enhancement (LGE) and acute edema in CMR
Time frame: within five days of admission to hospital
Rate of myocardial fibrosis with LGE and acute edema in CMR, suggesting a recent myocardial infarction (<1 month). CMR conducted at the fourth/fifth day after onset of the ischemic stroke.
Rate of signs of left ventricular dysfunction in the CMR
Time frame: within five days of admission to hospital
Rate of signs of left ventricular dysfunction in the cardiac MRI (i.e. reduced ejection fraction, end diastolic left ventricular volume, longitudinal strain rate). CMR conducted at the fourth/fifth day after onset of the ischemic stroke.
Rate of acute disturbance of microcirculation
Time frame: within five days of admission to hospital
Rate of acute disturbance of microcirculation (measurement on the basis of oxygen extraction in cardiac MRI). CMR conducted at the fourth/fifth day after onset of the ischemic stroke.
Rate of impaired left ventricular function and transient impaired left ventricular function in transthoracic echocardiography
Time frame: within seven days of admission to hospital
Rate of impaired left ventricular function (ejection fraction <50%, reduced global longitudinal strain etc.) in the transthoracic echocardiography as well as higher rate of transient left ventricular dysfunction detected in repeated transthoracic echocardiography (TTE). The TTE will be conducted at the first day after enrolment as well as at the day before discharge or five days after the first TTE respectively.
5 secondary outcomes
Rate of pathologic Periodic Repolarization Dynamics (PRDs) and Deceleration Capacity (DC)
Time frame: within seven days of admission to hospital
Difference in specific microRNA pattern in participants with myocardial damage induced by acute ischemic stroke
Time frame: within seven days of admission to hospital
Mortality
Time frame: at one week and twelve months after the initial event
Functional outcome
Time frame: at baseline, at seven days after baseline (or at day of discharge from hospital if <7d, respectively) and at twelve months after the initial event
Rate of cardiovascular events
Time frame: at one week and at twelve months after the initial event
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 30509695Scheitz JF, Nolte CH, Doehner W, Hachinski V, Endres M. Stroke-heart syndrome: clinical presentation and underlying mechanisms. Lancet Neurol. 2018 Dec;17(12):1109-1120. doi: 10.1016/S1474-4422(18)30336-3. Epub 2018 Oct 26.
- Background: PubMed 26933082Mochmann HC, Scheitz JF, Petzold GC, Haeusler KG, Audebert HJ, Laufs U, Schneider C, Landmesser U, Werner N, Endres M, Witzenbichler B, Nolte CH; TRELAS Study Group. Coronary Angiographic Findings in Acute Ischemic Stroke Patients With Elevated Cardiac Troponin: The Troponin Elevation in Acute Ischemic Stroke (TRELAS) Study. Circulation. 2016 Mar 29;133(13):1264-71. doi: 10.1161/CIRCULATIONAHA.115.018547. Epub 2016 Mar 1.
- Background: PubMed 27403291Rizas KD, Hamm W, Kaab S, Schmidt G, Bauer A. Periodic Repolarisation Dynamics: A Natural Probe of the Ventricular Response to Sympathetic Activation. Arrhythm Electrophysiol Rev. 2016 May;5(1):31-6. doi: 10.15420/aer.2015:30:2.
- Background: PubMed 33544087Stengl H, Ganeshan R, Hellwig S, Blaszczyk E, Fiebach JB, Nolte CH, Bauer A, Schulz-Menger J, Endres M, Scheitz JF. Cardiomyocyte Injury Following Acute Ischemic Stroke: Protocol for a Prospective Observational Cohort Study. JMIR Res Protoc. 2021 Feb 5;10(2):e24186. doi: 10.2196/24186.
- Background: PubMed 33372247Scheitz JF, Stengl H, Nolte CH, Landmesser U, Endres M. Neurological update: use of cardiac troponin in patients with stroke. J Neurol. 2021 Jun;268(6):2284-2292. doi: 10.1007/s00415-020-10349-w. Epub 2020 Dec 29.
- Derived from this study: PubMed 38410952Rosso M, Stengl H, Ganeshan R, Hellwig S, Klammer MG, von Rennenberg R, Bohme S, Nolte CH, Audebert HJ, Endres M, Kasner SE, Scheitz JF. Sex Differences in Outcomes of Acute Myocardial Injury After Stroke. J Am Heart Assoc. 2024 Mar 5;13(5):e032755. doi: 10.1161/JAHA.123.032755. Epub 2024 Feb 27.
- Individual participant dataSharing planned: No
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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.
Jan Scheitz, PD Dr. med. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Cardiac Complication, run by Charite University, Berlin, Germany at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Rate of myocardial edema without late gadolinium enhancement (native T1, T2 mapping) (time frame: within five days of admission to hospital). The study lists 5 primary outcomes in all. 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 NCT03892226, which also lists 6 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 20 Feb 2024.