Skip to main content
Clinical Trials/NL-OMON50610
NL-OMON50610
Withdrawn
Not Applicable

Immunological and Genetic Risk factors for Cardiac Serious Adverse Events following Controlled Human Malaria Infections: a Case-Control study - Risk factors for cardiac SAEs following CHMI

Radboud Universitair Medisch Centrum0 sites25 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocarditis (inflammation of the heart muscle) and acute coronary syndrome (range of conditions associated with sudden
Sponsor
Radboud Universitair Medisch Centrum
Enrollment
25
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

Similar Trials