Trial Outcomes & Findings for Assessment of Speckle Tracking Strain Predictive Value for Myocardial Fibrosis in Chagas Disease (NCT NCT02327052)

Results Overview

Longitudinal global strain were assesseb by standard transthoracic echocardiographic examinations were recorded in all subjects using the Vivid 7 digital ultrasound system (GE Vingmed Ultrasound AS, Horten, Norway) and myocardial fibrosis by cardiac magnetic resonance exams were performed on all subjects using the General Electric Sigma HDx 1.5-T system (Fairfield, CT, USA). .

Recruitment status

COMPLETED

Target enrollment

58 participants

Primary outcome timeframe

Both outcome measures will be assessed at one month of follow up.

Results posted on

2021-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	Chagas Disease The study comprised 58 subjects with Chagas disease, confirmed by two positive serologic tests, from a convenience sample.
Overall Study STARTED	58
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Speckle Tracking Strain Predictive Value for Myocardial Fibrosis in Chagas Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chagas Disease n=58 Participants See below Baseline Measures
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	58 years STANDARD_DEVIATION 9 • n=93 Participants
Sex: Female, Male Female	34 Participants n=93 Participants
Sex: Female, Male Male	24 Participants n=93 Participants
Region of Enrollment Brazil	58 participants n=93 Participants

PRIMARY outcome

Timeframe: Both outcome measures will be assessed at one month of follow up.

Longitudinal global strain were assesseb by standard transthoracic echocardiographic examinations were recorded in all subjects using the Vivid 7 digital ultrasound system (GE Vingmed Ultrasound AS, Horten, Norway) and myocardial fibrosis by cardiac magnetic resonance exams were performed on all subjects using the General Electric Sigma HDx 1.5-T system (Fairfield, CT, USA). .

Outcome measures

Outcome measures
Measure	Chagas Disease n=58 Participants The study comprised 58 subjects with Chagas disease, confirmed by two positive serologic tests.
Correlation Between Longitudinal Global Strain and the Percentage of Myocardial Fibrosis on Magnetic Resonance	16.8 percentage of fibrosis Standard Deviation 5.5

Adverse Events

Chagas Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Milena Botelho Pereira Soares

Hospital São Rafael

Phone: +557132816455

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place