Myocarditis (inflammation of the heart muscle) and acute coronary syndrome (range of conditions associated with sudden reduced blood flow to the heart)
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study as a case, a subject must meet all of the following criteria: 1. Subject must sign written informed consent to participate in the trial. 2. By judgement of the clinical investigator, the subject is able to understand the planned study procedures and (limited) risks associated with the study, inc. the risk of incidental findings in genetic analysis. 3. The subject was enrolled in a CHMI study performed by the Radboudumc between January 1998 and December 2021 and was subjected to a Controlled Human Malaria Infection. Subject developed a cardiac serious adverse event in the period of 20 days following CHMI. A cardiac SAE is defined as either clinically significant increased troponin levels and/or diagnosis of myocarditis, acute coronary syndrome or myocardial infarction by a cardiologist, and meet the criteria of an SAE as defined in the study protocol. 4. Subjects unwilling and/or unable to participate in genetic analysis, are still eligible for immunological analysis (and vice versa). In order to be eligible to participate in this study as a control, a subject must meet all of the following criteria: 1. The subject has signed written informed consent. 2. The subject is able to understand the study procedures and (limited) risks associated with the study. 3. The subject was enrolled in a CHMI study performed by the Radboudumc between January 1998 and December 2021 and was subjected to a Controlled Human Malaria Infection. Subject did not develop a cardiac serious adverse event in the period of 20 days following CHMI. A cardiac SAE is defined as either clinically significant increased troponin levels and/or diagnosis of myocarditis, acute coronary syndrome or myocardial infarction by a cardiologist, and meets the criteria of an SAE as defined in the respective study protocol.
Exclusion criteria
Exclusion criteria: A potential case or control subject who meets any of the following criteria will be excluded from participation in immunological screening: 1. Subject is HIV-positive or suffers from any other (acute or chronic) disease as determined by medical history, physical examination or laboratory screening tests which according to the clinical judgment of the investigator leads to undesirable interference with the results of the immunological tests. The clinical investigator will consider whether blood samples without such interference can be obtained later in the study period (e.g. in case of acute infectious disease). 2. Use or receipt of i) immunosuppressive drugs or other immune modifying drugs within three months prior to blood sampling for immunological screening (inhaled and topical corticosteroids and oral anti-histamines exempted) OR ii) use of illicit drugs determined through urine drug screening OR iii) any vaccinations within 30 days prior to immunology blood sampling IF use of these drugs or receipt of a vaccination lead to undesirable interference with the results of the immunological tests according to the clinical judgment of the investigator. The clinical investigator will consider whether blood samples without such interference can be obtained later in the study period. 3. Any history of malaria other than CHMI as part of the Radboudumc trial in which the subject has previously participated. A potential case subject who meets any of the following criteria will be excluded from participation in genetic analysis: 1. A history of bone marrow transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Immunological risk factors with significant odds ratios for cardiac SAEs following CHMI, i.e. in cases compared to controls. 2. Genetic factors/deviations/variants identified in one or more cases which can (possibly and/or partially) explain why these subjects suffered cardiac SAEs following CHMI. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Immunological factors/deviations/variants identified in one or more cases which can (possibly and/or partially) explain why these subjects suffered cardiac SAEs following CHMI. | — |
Countries
Netherlands
Outcome results
None listed