Clinical Assessment, Neuroimaging and Immunomarkers in Chagas Disease Study (CLINICS)

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study is to determine noninvasive markers of brain involvement in Chagas disease. In a subgroup of patients with high intensity transient signals (HITS) on transcranial Doppler monitorization, the investigators aim to determine the efficacy and safety of aspirin in preventing microembolization in patients with no previous history of stroke. Specific aims are listed bellow:

(1) to establish brain magnetic resonance imaging markers of stroke risk in patients with Chagasic heart failure (HF); (2) to determine whether biomarkers can predict stroke risk in patients with Chagasic HF; and (3) to evaluate the efficacy of antiplatelet treatment in decreasing microembolization rate in patients with Chagasic HF.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of Bahia
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health (NIH)
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Diagnosis of heart failure according to Framingham criteria

• Informed consent

• Age 18 years or above

Exclusion Criteria:

• Patients with a history of an untreated malignancy (except local skin cancers)

• Ischemic stroke (determined using the Questionnaire for Verifying Stroke-Free Status (QVSFS)

• Patients on renal dialysis or with end-stage hepatic dysfunction

• Acute infection/inflammation (Temperature > 101.5 F, and/or WBC> 15, 000)

• Inability to obtain informed consent from patient or next of kin

• Anticoagulant use (warfarin or heparin)