Clinical Assessment, Neuroimaging and Immunomarkers in Chagas Disease Study (CLINICS) (NCT01650792) | Clinical Trial Compass
UnknownPhase 4
Clinical Assessment, Neuroimaging and Immunomarkers in Chagas Disease Study (CLINICS)
Brazil500 participantsStarted 2012-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Brain magnetic resonance imaging lesions
Timeframe: Baseline cross-sectional data
2
Biomarkers
Timeframe: Baseline cross-sectional data
3
Proportion of high intensity transient signals on transcranial Doppler monitorization