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Cardiomyocyte Injury Following Acute Ischemic Stroke (CORONA-IS)

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ClinicalTrials.gov Identifier: NCT03892226
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. med. Jan Friedrich Scheitz, Charite University, Berlin, Germany

Brief 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.

Condition or disease
Stroke, Ischemic Cardiac Complication

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiomyocyte Injury Following Acute Ischemic Stroke
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Group/Cohort
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)



Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Rate of pathologic Periodic Repolarization Dynamics (PRDs) and Deceleration Capacity (DC) [ Time Frame: within seven days of admission to hospital ]
    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).

  2. Difference in specific microRNA pattern in participants with myocardial damage induced by acute ischemic stroke [ Time Frame: within seven days of admission to hospital ]
    Analysis of circulating microRNA pattern via next generation Sequencing in patient's blood samples.

  3. Mortality [ Time Frame: at one week and twelve months after the initial event ]
    mortality (rate of deaths) will be recorded during the stay in hospital as well as after twelve months

  4. 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 ]
    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)

  5. Rate of cardiovascular events [ Time Frame: at one week and at twelve months after the initial event ]
    cardiovascular events include new stroke, transient ischemic attack and myocardial infarction



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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 hospital's stroke unit will be systematically screened for eligibility
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

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): NCT03892226


Contacts
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Contact: Helena Stengl +49 30 450 560624 helena.stengl@charite.de
Contact: Ramanan Ganeshan, Dr. med. +49 30 450 560624 ramanan.ganeshan@charite.de

Locations
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Germany
Charité-Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Jan Scheitz    004930450560624    jan.scheitz@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Jan Scheitz, PD Dr. med. Charite University, Berlin, Germany
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. med. Jan Friedrich Scheitz, Principal Investigator, Clinician Scientist, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03892226    
Other Study ID Numbers: EA4/123/18
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
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 Dr. med. Jan Friedrich Scheitz, Charite University, Berlin, Germany:
stroke
stroke-heart syndrome
troponin
myocardial stunning
acute coronary syndrome
periodic repolarization dynamics
cardiac complications
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes