Clinical Assessment, Neuroimaging and Immunomarkers in Chagas Disease Study (CLINICS) (CLINICS)
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|ClinicalTrials.gov Identifier: NCT01650792|
Recruitment Status : Recruiting
First Posted : July 26, 2012
Last Update Posted : July 22, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Chagas Disease With Heart Failure||Drug: Aspirin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||CHADSS: Chagas Disease Scan Study|
|Actual Study Start Date :||July 2012|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Aspirin
Aspirin 300mg per day for 7 days in patients with HITS on transcranial Doppler monitorization
No Intervention: Best medical treatment
Best medical treatment including drugs for heart failure and hypertension will be given to both groups.
- Brain magnetic resonance imaging lesions [ Time Frame: Baseline cross-sectional data ]Primary hypothesis is that silent brain infarcts, brain atrophy and white matter disease will be more common in patients with Chagas disease heart failure when compared to other etiologies of heart failure.
- Biomarkers [ Time Frame: Baseline cross-sectional data ]Primary hypothesis is that serum biomarkers orosomucoid, neprilysin, interleukin-6 and matrix metalloproteinase-9 will be increased in Chagas disease heart failure when compared to other etiologies of heart failure
- Proportion of high intensity transient signals on transcranial Doppler monitorization [ Time Frame: One week ]Primary hypothesis is that the proportion of patients with high intensity transient signals (HITS) on one-hour transcranial Doppler monitorization after one-week treatment with 300mg aspirin and best medical treatment will be less when compared with best medical treatment without aspirin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650792
|Contact: Jamary Oliveira-Filho, MD, PhDemail@example.com|
|Hospital Universitario Professor Edgard Santos||Recruiting|
|Salvador, Bahia, Brazil, 40110060|
|Principal Investigator: Jamary Oliveira-Filho, MD, PhD|
|Principal Investigator:||Jamary Oliveira-Filho, MD, PhD||Associate Professor, Federal University of Bahia|