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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05288426
Other study ID # DM005
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date December 1, 2025

Study information

Verified date March 2022
Source Hadassah Medical Organization
Contact Dror Mevorach, MD
Phone 972-2- 6777317
Email mevorachd@hadassah.org.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

BNT162b2 vaccine has become one of the most prevalent vaccines against the COVID-19 and is currently the main vaccine used in Israel. Since marketing and the beginning of use of the vaccine, we and others have reported. of the development of post vaccination myocarditis. In this study the investigators wish to explore the long term impact on 150 patients who have been diagnosed with myocarditis or multisystem inflammatory syndrome (MIS) in the year following their diagnosis of Myocarditis.


Description:

Aim of Study The primary aim of the study is to evaluate the impact of long term impact of myocarditis which has been developed secondary to Covid 19 vaccine or Covid 19 infection. The primary end points of the study will be functional evaluations of the patients using clinical evaluation that includes questionnaires, ECG findings, evaluation of the systolic and diastolic function of the heart using echocardiogram or cardiac MRI, laboratory tests including troponin, CPK, CRP, Pro-BNP, and cytokines/chemokines. Methods In this prospective study patients will be recruited from health care providers The selected patients will come to Hadassah hospital within 6 and 12 months after they have been diagnosed with myocarditis. Upon the patients arrival they will sign the informed consent, the investigators will draw blood tests and the participants will perform an echocardiogram according to the special protocol and will perform cardiac- MRI according to the myocarditis protocol. Patients will fulfill health questionnaires. that may include 36 Health Survey Questionnaire (SF-36); Scores on the European Quality of Life-5 Dimensions (EQ-5D) survey, which is also health-related quality of life score; the Scores on the European Quality of Life Visual Analogue Scale (EQ-VAS); Kansas City Cardiomyopathy Questionnaire (KCCQ). the Investigators will obtain blood samples from all the patients: complete blood count, c- reactive protein, troponin, CPK, Pro-BNP, liver and kidney functions, magnesium and cytokines. In addition, all participants will undergo echocardiogram test to evaluate their systolic and diastolic function of the heart. Ethical Considerations The study poses no danger to the participants. It has the potential to improve the understanding of the impact myocarditis post COVID-19 MRNA vaccine on the quality of life of those patients and provide a descent follow-up for the participant. Any participant will sign on informed consent form.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 1, 2025
Est. primary completion date May 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Adult males and females. - Minors male and female. Diagnosed as myocarditis: - Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury (TNI and CK-MB and BNP or NT-pro-BNP) - Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain, and/or syncope; - Image for cardiac injury: marked diffused reduction in left ventricle wall movement, with dramatically decreased left ventricle ejection fraction (LVEF) < 45%, or by cardiac magnetic resonance imaging. Exclusion Criteria: - Also considering acute coronary syndrome but unable to perform coronary angiography to distinguish acute coronary syndrome from myocarditis, or otherwise suffer from valvuloplasty. - Myocardial injury caused by sepsis, medical agents, or poisons; - Malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
This is an observational study, with no intervention.

Locations

Country Name City State
Israel Hadassah Medical Center Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. — View Citation

Mevorach D, Anis E, Cedar N, Bromberg M, Haas EJ, Nadir E, Olsha-Castell S, Arad D, Hasin T, Levi N, Asleh R, Amir O, Meir K, Cohen D, Dichtiar R, Novick D, Hershkovitz Y, Dagan R, Leitersdorf I, Ben-Ami R, Miskin I, Saliba W, Muhsen K, Levi Y, Green MS, Keinan-Boker L, Alroy-Preis S. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. N Engl J Med. 2021 Dec 2;385(23):2140-2149. doi: 10.1056/NEJMoa2109730. Epub 2021 Oct 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To assess troponin levels in patients that developed acute myocarditis troponin levels in each clinical visit will be documented 3 years
Primary To assess PRO-BNP levels in patients that developed acute myocarditis PRO-BNP levels in each clinical visit will be documented 3 years
Primary To assess CRP levels in patients that developed acute myocarditis CRP levels in each clinical visit will be documented 3 years
Primary To assess cardiac MRI in patients that developed acute myocarditis Cardiac MRI will be performed at least yearly and evaluated for regionally increased signal in T2-weighted images; Late gadolinium enhancement in a nonischemic pattern, Increased native T1 values on a 3T magnet. 3 years
Primary To assess echocardiogram in patients that developed acute myocarditis echocardiogram will be performed at least yearly and defined as normal, ST-segment elevation, with Diffuse or Non-diffuse changes, T-wave changes, Atrial fibrillation or non-sustained ventricular tachycardia. 3 years
Primary To assess health quality by a questionnaire in patients that developed acute myocarditis EQ-5D will be fill at least once a year. Descriptive analysis of EQ-5D profile at each observation and analysis of changes between repeated observations. Cluster analysis can be used. 3 years
Primary To assess heart failure questionnaire in patients that developed acute myocarditis KCCQ will be fill at least once a year. 3 years
Secondary Cytokine in Patients after myocarditis To assess cytokines by measuring the serum concentrations 3 years
Secondary Chemokine in Patients after myocarditis To assess chemokines by measuring the serum concentrations 3 years
Secondary Hematopoietic Growth Factors (HGF)in patients after myocarditis To assess Hematopoietic Growth Factors in patients with COVID-19 by measuring the To assess HGF by measuring the serum concentrations 3 years
Secondary Complement in patients after myocarditis assess complement factors by measuring the serum concentrations 3 years
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