An observational study in Coarctation of Aorta, sponsored by Beijing Institute of Heart, Lung and Blood Vessel Diseases. Status unknown at 1 site in China. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by Beijing Institute of Heart, Lung and Blood Vessel Diseases · Observational
This is a systemic research of Chinese aortic coarctation patients, aiming to determine risk factors and serial biomarkers of aortic coarctation in prognosis.
The goal is to determine how much the left ventricle remodeling pre-operation and how it changes in the following-up duration after surgery, so does in the blood pressure and heart function. Risk factors associated with complications and prognosis are investigated and analyzed. Identification of novel biomarkers is needed to help predicting the prognosis, such as the left ventricle anti-remodeling, heart function and blood pressure improvement, as well as the exercise tolerance post-operation. The findings of this study will help the investigators developping new tests to monitor affected patients and optimize the operation as well as the follow-up procedure.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 29 observational studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →Beijing Institute of Heart, Lung and Blood Vessel Diseases is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with coarctation of the aorta, treated after 2002 in Beijing Anzhen Hospital.
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Exclusion Criteria:
Patients diagnosed as aortic coarctation and undergone corrected procedures from 2002 to Feb 28th 2019 were recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography.
Patients diagnosed as aortic coarctation and undergone corrected procedures after Mar. 1st 2019 will be recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography.
Change in left ventricular mass
Left ventricular mass will be measured by 2D echocardiography. For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.
Time frame: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
Hypertension
Both resting blood pressure and exercise-related blood pressure will be assessed for patients above 5 years old during the follow-up visit.
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Left ventricular systolic function
Left ventricular systolic function assessed by echocardiography
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Left ventricular diastolic function
Left ventricular diastolic function assessed by echocardiography (TDI)
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Left ventricular systolic heart function of longitudinal myocardium
Left ventricular systolic heart function of longitudinal myocardium assessed by echocardiography (M mode Doppler).
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Exercise tolerance
Six minutes walking distance will be recorded and analyzed to evaluate the exercise tolerance. Echocardiographic images will be obtained after six minutes walking to assess the reserve function of left ventricle. Blood pressure will also be taken immediately after the Six minutes walking to analyze exercise-induced hypertension.
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Biomarkers of vascular inflammation
Biomarkers of inflammation (hs-CRP). For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.
Time frame: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
Biomarkers of left ventricle remodeling
Biomarkers of left ventricle remodeling (ST2)
Time frame: For the retrospective cohort, follow-up visit of 1 month to 20 years after primary treatment. For the prospective cohort, the data is collected prior to primary treatment and during follow-up visit of one year after primary treatment
Biomarkers of left heart function
Biomarkers of left heart function (BNP). For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.
Time frame: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
Biomarkers of hypertension phenotype related to aortic coarctation
Biomarkers of hypertension phenotype related to aortic coarctation
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Recoarctation
Recoarctation assessed by echocardiography or computed tomography angiography.
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
All-cause death
The data is collected during follow-up visit at follow-up time point.
Time frame: 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Started Mar 2019 (actual). Primary completion is estimated for Dec 2022, 45 months after the start.
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This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Beijing Institute of Heart, Lung and Blood Vessel Diseases