Chagas DiseaseNCT02327052
Assessment of Speckle Tracking Strain Predictive Value for Myocardial Fibrosis in Chagas Disease
An observational study of Chagas Disease, run by Hospital Sao Rafael at 1 site in Brazil.
Trial summary
One of the most challenging issues of chronic Chagas disease is to provide earlier detection of heart involvement. Two-dimensional speckle tracking (2-D ST) echocardiography, a new imaging modality with useful applications in several cardiac diseases, has been validated for subjects with myocardial infarction against… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chagas Disease
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects in the Chagas disease outpatient clinics at our institution from January 2011 to December 2013 were invited to participate in this study.
Who may be able to join
- Chagas disease, established based on microbiological confirmation by two positive serologic tests (indirect hemagglutination and indirect immunofluorescence)
- Between 18 and 70 years of age.
Who cannot join
- Previous myocardial infarction or history of coronary artery disease
- Primary valve disease
- Dialysis treatment of terminal renal failure
- Liver disease in activity
- Hematologic, neoplastic or bone diseases
- And MRI contraindications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Speckle Tracking Strain Predictive Value for Myocardial Fibrosis in Subjects With Chagas Disease
One of the most challenging issues of chronic Chagas disease is to provide earlier detection of heart involvement. Two-dimensional speckle tracking (2-D ST) echocardiography, a new imaging modality with useful applications in several cardiac diseases, has been validated for subjects with myocardial infarction against cardiac magnetic resonance (CMR). Here the investigators hypothesize that the longitudinal global strain (LGS) has an incremental value to ejection fraction for predicting myocardial fibrosis in subjects with Chagas disease.
Read the detailed description
We conducted a cross-sectional study, in which adult subjects with Chagas disease were invited to participate. From January 2011 to December 2013, we included 58 subjects from a convenience sample, in the Chagas disease outpatient clinics at our institution. Inclusion criteria were disease established based on microbiological confirmation by two positive serologic tests (indirect hemagglutination and indirect immunofluorescence), and age between 18 and 70 years. Exclusion criteria were: previous myocardial infarction or history of coronary artery disease; primary valve disease; dialysis treatment of terminal renal failure, liver disease in activity; hematologic, neoplastic or bone diseases; and MRI contraindications.
The study complied with the Declaration of Helsinki and was approved by the Ethics Committee of the Hospital São Rafael. All subjects gave written informed consent before their inclusion in the study.
We obtained a structured medical history, and all subjects underwent physical examination, blood analysis, 12-lead ECG, chest X-Ray, 24-h Holter monitoring, conventional Doppler echocardiogram plus speckle tracking strain, and cardiac magnetic resonance.
Doppler echocardiogram Standard transthoracic echocardiographic examinations were recorded in all subjects using the Vivid 7 digital ultrasound system (GE Vingmed Ultrasound AS, Horten, Norway). Three cardiac cycles were stored in cine loop format for online analysis. LV and left atrial dimensions were measured according to the American Society of Echocardiography's recommendations [13]. The LV EF was measured using the biplane Simpson's method. S0 systolic velocity at the lateral mitral annulus was assessed using pulsed-wave DTI. Diastolic function was evaluated by the analysis of the mitral Doppler inflow, pulsed- wave DTI at the lateral mitral annulus, and mitral propagation velocity using color M-mode echocardiography. Mitral regurgitation (MR) was obtained using the proximal isovelocity surface area method. Right ventricular function was assessed with the S0 systolic velocity in the lateral wall. Systolic pulmonary arterial pressure was obtained from the tricuspid regurgitation flow. In subjects with adequate Doppler MR signals, dP/dt was determined noninvasively from the rate of change of MR velocity, according to American Society of Echocardiography guidelines.
Strain Measurements Two-dimensional gray-scale images were acquired in the standard apical four-chamber, three-chamber, and two-chamber views at a frame rate of 80 frames/sec. The dimensions of the computation area were an angle of 80o and at a depth of 13 cm. The left ventricle was divided into 17 segments, and each segment was analyzed individually. GLS and segmental longitudinal strain were obtained as previously described [14]. Average longitudinal strains were calculated automatically by the software. Two-dimensional strain is a non-Doppler-based method for the evaluation of systolic strain using standard 2D acquisitions. After placing three endocardial markers in an end-diastolic frame, the software automatically tracks the contour on subsequent frames. Adequate tracking can be verified in real time and corrected by adjusting the region of interest or by manually correcting the contour to ensure optimal tracking. Two-dimensional longitudinal strain was assessed in apical views. Average longitudinal strains were calculated for the 17 segments.
Magnetic resonance imaging Cardiac magnetic resonance exams were performed on all subjects using the General Electric Sigma HDx 1.5-T system (Fairfield, CT, USA). Images were acquired and gated to the ECG during breath-hold, four-chamber, short axis and long axis of the left ventricle, in the exact same location in different sequences. This allows a precise comparison between cardiac function and regional myocardial structure. The parameters used in the dynamic sequences were repetition time (RT) of 3.5 ms, echo time (ET) of 1.5 ms, flip angle 60°, bandwidth of receipt of ± 125 kHz, field of view (FOV) of 35 x 35 cm, 256x148 matrix, temporal resolution (TR) 35 ms, 8.0 mm slice thickness, without a space between the slices. Following this acquisition, a dose of gadolinium-based contrast (0.1 mmol / kg) was injected. The myocardial delayed enhancement (MDE) technique was used to investigate myocardial fibrosis, an inversion-recovery pre-pared gradient-echo acquired 10 to 20 min after contrast application, with the following parameters: Repetition time (RT) 7.1 ms, echo time (ET) 3.1 ms, flip angle 20°, cardiac phases 1, views per segment 16 to 32, matrix 256 X 192, slice thickness 8 mm, gap between slices 2 mm and field of view 32 to 38 cm, inversion time 150 to 300 ms, receiver bandwidth 31.25 kHz, number of excitations 2, acquisition every heart beat. The mass of fibrosis was estimated by a quantitative visual method.
Statistical analysis Categorical data were presented as numbers (percentages), and continuous data were expressed as mean (SD) or median (interquartile range). Comparisons of continuous variables among groups were performed with analysis of variance (ANOVA) test or Kruskal-Wallis, depending on normality assessed by Shapiro-Wilk test. Chi-Square or Fisher tests were applied for proportions comparisons. Correlations between continuous variables were evaluated by Pearson or Spearman coefficients, depending on normality. Receiver-operating characteristic (ROC) curve analysis was used to evaluate if the longitudinal global strain would add accuracy to the ejection fraction in the predicted fibrosis. C-Statistic (area under the curve) was presented as a unified estimate of sensitivity and specificity. To determine the ability to predict myocardial fibrosis, multiple linear regression was performed, adjusting longitudinal global strain to left ventricular ejection fraction. Analyses in subgroups with normal and low ejection fraction were also accomplished. Cases with missing data were not included in the analysis. Analyses were performed using SPSS version 20.0 (IBM), and p < 0.05 (two-tailed) was considered statistically significant.
- Conditions
- Chagas Disease
- Being tested
- No intervention was performed.
- Keywords
- Chagas disease, longitudinal global strain, speckle tracking
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was performed.Other
No intervention was performed.
| Study group | Role | What they receive |
|---|---|---|
| Chagas disease | The study comprised 58 subjects with Chagas disease, confirmed by two positive serologic tests. Receives: Other: No intervention was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Longitudinal Global Strain and the Percentage of Myocardial Fibrosis on Magnetic Resonance
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).
.
Measured: Both outcome measures will be assessed at one month of follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chagas DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Rafael
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milena Botelho Pereira Soares, Hospital Sao Rafael
- Investigators
- Milena Soares, PhD, Principal investigator, Hospital São Rafael
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327052
- Sponsor's protocol ID
- PCL01-04
- Status last verified
- Mar 2021
- First submitted
- 18 Dec 2014
- Last updated
- 24 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Speckle Tracking Strain Predictive Value for Myocardial Fibrosis in Subjects With Chagas Disease
- ClinicalTrials.gov ID
- NCT02327052
- Acronym / sponsor ID
- PCL01-04
- Conditions
- Chagas Disease
- Keywords
- Chagas disease, longitudinal global strain, speckle tracking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hospital Sao RafaelUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Posted 24 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the most challenging issues of chronic Chagas disease is to provide earlier detection of heart involvement. Two-dimensional speckle tracking (2-D ST) echocardiography, a new imaging modality with useful applications in several cardiac diseases, has been validated for subjects with myocardial infarction against cardiac magnetic resonance (CMR). Here the investigators hypothesize that the longitudinal global strain (LGS) has an incremental value to ejection fraction for predicting myocardial fibrosis in subjects with Chagas disease.
Detailed description
We conducted a cross-sectional study, in which adult subjects with Chagas disease were invited to participate. From January 2011 to December 2013, we included 58 subjects from a convenience sample, in the Chagas disease outpatient clinics at our institution. Inclusion criteria were disease established based on microbiological confirmation by two positive serologic tests (indirect hemagglutination and indirect immunofluorescence), and age between 18 and 70 years. Exclusion criteria were: previous myocardial infarction or history of coronary artery disease; primary valve disease; dialysis treatment of terminal renal failure, liver disease in activity; hematologic, neoplastic or bone diseases; and MRI contraindications.
The study complied with the Declaration of Helsinki and was approved by the Ethics Committee of the Hospital São Rafael. All subjects gave written informed consent before their inclusion in the study.
We obtained a structured medical history, and all subjects underwent physical examination, blood analysis, 12-lead ECG, chest X-Ray, 24-h Holter monitoring, conventional Doppler echocardiogram plus speckle tracking strain, and cardiac magnetic resonance.
Doppler echocardiogram Standard transthoracic echocardiographic examinations were recorded in all subjects using the Vivid 7 digital ultrasound system (GE Vingmed Ultrasound AS, Horten, Norway). Three cardiac cycles were stored in cine loop format for online analysis. LV and left atrial dimensions were measured according to the American Society of Echocardiography's recommendations [13]. The LV EF was measured using the biplane Simpson's method. S0 systolic velocity at the lateral mitral annulus was assessed using pulsed-wave DTI. Diastolic function was evaluated by the analysis of the mitral Doppler inflow, pulsed- wave DTI at the lateral mitral annulus, and mitral propagation velocity using color M-mode echocardiography. Mitral regurgitation (MR) was obtained using the proximal isovelocity surface area method. Right ventricular function was assessed with the S0 systolic velocity in the lateral wall. Systolic pulmonary arterial pressure was obtained from the tricuspid regurgitation flow. In subjects with adequate Doppler MR signals, dP/dt was determined noninvasively from the rate of change of MR velocity, according to American Society of Echocardiography guidelines.
Strain Measurements Two-dimensional gray-scale images were acquired in the standard apical four-chamber, three-chamber, and two-chamber views at a frame rate of 80 frames/sec. The dimensions of the computation area were an angle of 80o and at a depth of 13 cm. The left ventricle was divided into 17 segments, and each segment was analyzed individually. GLS and segmental longitudinal strain were obtained as previously described [14]. Average longitudinal strains were calculated automatically by the software. Two-dimensional strain is a non-Doppler-based method for the evaluation of systolic strain using standard 2D acquisitions. After placing three endocardial markers in an end-diastolic frame, the software automatically tracks the contour on subsequent frames. Adequate tracking can be verified in real time and corrected by adjusting the region of interest or by manually correcting the contour to ensure optimal tracking. Two-dimensional longitudinal strain was assessed in apical views. Average longitudinal strains were calculated for the 17 segments.
Magnetic resonance imaging Cardiac magnetic resonance exams were performed on all subjects using the General Electric Sigma HDx 1.5-T system (Fairfield, CT, USA). Images were acquired and gated to the ECG during breath-hold, four-chamber, short axis and long axis of the left ventricle, in the exact same location in different sequences. This allows a precise comparison between cardiac function and regional myocardial structure. The parameters used in the dynamic sequences were repetition time (RT) of 3.5 ms, echo time (ET) of 1.5 ms, flip angle 60°, bandwidth of receipt of ± 125 kHz, field of view (FOV) of 35 x 35 cm, 256x148 matrix, temporal resolution (TR) 35 ms, 8.0 mm slice thickness, without a space between the slices. Following this acquisition, a dose of gadolinium-based contrast (0.1 mmol / kg) was injected. The myocardial delayed enhancement (MDE) technique was used to investigate myocardial fibrosis, an inversion-recovery pre-pared gradient-echo acquired 10 to 20 min after contrast application, with the following parameters: Repetition time (RT) 7.1 ms, echo time (ET) 3.1 ms, flip angle 20°, cardiac phases 1, views per segment 16 to 32, matrix 256 X 192, slice thickness 8 mm, gap between slices 2 mm and field of view 32 to 38 cm, inversion time 150 to 300 ms, receiver bandwidth 31.25 kHz, number of excitations 2, acquisition every heart beat. The mass of fibrosis was estimated by a quantitative visual method.
Statistical analysis Categorical data were presented as numbers (percentages), and continuous data were expressed as mean (SD) or median (interquartile range). Comparisons of continuous variables among groups were performed with analysis of variance (ANOVA) test or Kruskal-Wallis, depending on normality assessed by Shapiro-Wilk test. Chi-Square or Fisher tests were applied for proportions comparisons. Correlations between continuous variables were evaluated by Pearson or Spearman coefficients, depending on normality. Receiver-operating characteristic (ROC) curve analysis was used to evaluate if the longitudinal global strain would add accuracy to the ejection fraction in the predicted fibrosis. C-Statistic (area under the curve) was presented as a unified estimate of sensitivity and specificity. To determine the ability to predict myocardial fibrosis, multiple linear regression was performed, adjusting longitudinal global strain to left ventricular ejection fraction. Analyses in subgroups with normal and low ejection fraction were also accomplished. Cases with missing data were not included in the analysis. Analyses were performed using SPSS version 20.0 (IBM), and p < 0.05 (two-tailed) was considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chagas disease | – | Other: No intervention was performed.The study comprised 58 subjects with Chagas disease, confirmed by two positive serologic tests. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects in the Chagas disease outpatient clinics at our institution from January 2011 to December 2013 were invited to participate in this study.
Key inclusion criteria (2 listed)
- Chagas disease, established based on microbiological confirmation by two positive serologic tests (indirect hemagglutination and indirect immunofluorescence)
- Between 18 and 70 years of age.
Key exclusion criteria (6 listed)
- Previous myocardial infarction or history of coronary artery disease
- Primary valve disease
- Dialysis treatment of terminal renal failure
- Liver disease in activity
- Hematologic, neoplastic or bone diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention was performed.No intervention was performed. | Other | Chagas disease |
Primary outcome
Correlation Between Longitudinal Global Strain and the Percentage of Myocardial Fibrosis on Magnetic Resonance
Time frame: 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). .
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milena Soares, PhD principal investigator
Hospital São Rafael
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chagas Disease, run by Hospital Sao Rafael at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Longitudinal Global Strain and the Percentage of Myocardial Fibrosis on Magnetic Resonance (time frame: Both outcome measures will be assessed at one month of follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.