Characterization of the Cardiac Reinnervation of Patients With Transposition of the Great Arteries Long After Repair With the Arterial Switch Operation. Correlation With Electrocardiographic and Exercise Test Parameters
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03469843|
Recruitment Status : Not yet recruiting
First Posted : March 19, 2018
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment|
|Congenital Heart Disease Congenital Heart Defect Transposition of the Great Arteries||Other: Non intervention|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Characterization of the Cardiac Reinnervation of Patients With Transposition of the Great Arteries Long After Repair With the Arterial Switch Operation. Correlation With Electrocardiographic and Exercise Test Parameters|
|Estimated Study Start Date :||March 26, 2018|
|Estimated Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
patients with transposition of the great arteries long after repair with the arterial switch operation
Other: Non intervention
patients without intervention
Other Name: patients without intervention
- Myocardial innervation pattern on 123I-mlBG SPECT. [ Time Frame: 1 day ]To describe the myocardial reinnervation pattern of a cohort of patients with TGA long after ASO using cardiac nuclear imaging.
- Myocardial perfusion defects on cardiac nuclear imaging. [ Time Frame: 1 day ]To identify myocardial perfusion defects using cardiac nuclear imaging.
- Myocardial innervation perfusion mismatch defects on cardiac nuclear imaging. [ Time Frame: 1 day ]To identify myocardial innervations/perfusion mismatch using cardiac nuclear imaging.
- Treadmill exercise test. [ Time Frame: 1 day ]
To determine exercise capacity (METs and double product) and chronotropic response (Maximal heart rate and heart rate increase pattern). Correlate with myocardial reinnervation pattern and sinus node reinnervation.
To determine exercise induced ischeamic ST segment changes. Correlate with myocardial perfusion defects and innervation-perfusion mismatch.
- 24 hours ECG Holter monitoring . [ Time Frame: 1 day ]To determine sinus node innervation through heart rate variability (HRV) which will be assessed by time domain variables (the standard deviation of normal RR intervals (SDNN) and the square root of the mean of the squared differences between adjacent normal RR intervals (r-MSSD)) and frequency domain variables (variance of all R-R intervals - total power (TP); power in the very low frequency range - very low frequency (VLF, 0.003-0.04 Hz); power in the low frequency range-low frequency (LF, 0.04-0.15Hz); low frequency power in normalized units-normalized low frequency; power in the high frequency range-high frequency (HF, 0.15-0.40 Hz); and high frequency power in normalized units-normalized high frequency and the ratio of low frequency to high frequency (LF/HF)).
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): NCT03469843
|Contact: Laura Dos Subirà, PhD MDemail@example.com|
|Contact: Paula Resta Bond, MDfirstname.lastname@example.org|
|Principal Investigator:||Laura Dos Subirà, PhD MD||Hospital Universitari Vall d`Hebron , Barcelona, Spain|