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出境医 / 临床实验 / Prognosis and Integrative Assessment of Aortic Coarctation Patients in China
Prognosis and Integrative Assessment of Aortic Coarctation Patients in China
Study Description
Brief Summary:
This is a systemic research of Chinese aortic coarctation patients, aiming to determine risk factors and serial biomarkers of aortic coarctation in prognosis.
| Condition or disease |
|---|
| Coarctation of Aorta |
Detailed Description:
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.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Official Title: | Prognosis and Integrative Assessment of Aortic Coarctation Patients in CHINA |
| Actual Study Start Date : | March 1, 2019 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | December 31, 2023 |
Arms and Interventions
| Group/Cohort |
|---|
|
Retrospective Cohort of Aortic Coarctation
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.
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Perspective Cohort of Aortic Coarctation
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.
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Outcome Measures
Primary Outcome Measures :
- Change in left ventricular mass [ 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) ]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.
- Hypertension [ Time Frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort ]Both resting blood pressure and exercise-related blood pressure will be assessed for patients above 5 years old during the follow-up visit.
Secondary Outcome Measures :
- Left ventricular systolic function [ 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 assessed by echocardiography
- Left ventricular diastolic function [ 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 assessed by echocardiography (TDI)
- Left ventricular systolic heart function of longitudinal myocardium [ 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 assessed by echocardiography (M mode Doppler).
- Exercise tolerance [ Time Frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort ]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.
- Biomarkers of vascular inflammation [ 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 inflammation (hs-CRP). For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.
- Biomarkers of left ventricle remodeling [ 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 ventricle remodeling (ST2)
- Biomarkers of left heart function [ 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 heart function (BNP). For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.
- 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 ]Biomarkers of hypertension phenotype related to aortic coarctation
- Recoarctation [ Time Frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort ]Recoarctation assessed by echocardiography or computed tomography angiography.
- All-cause death [ Time Frame: 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort ]The data is collected during follow-up visit at follow-up time point.
Biospecimen Retention: Samples With DNA
If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA. If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid nitrogen.
Eligibility Criteria
| Ages Eligible for Study: | up to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with coarctation of the aorta, treated after 2002 in Beijing Anzhen Hospital.
Criteria
Inclusion Criteria:
- Diagnosis of isolated coarctation of the aorta, or accompanied with atrial septal defect(ASD), ventricular septal defect (VSD), patent ductus arteriosus( PDA), patent foramen ovale (PFO);
- Patients who can cooperation with study procedures.
Exclusion Criteria:
- Co-morbidities that may independently affect cardiovascular function, including associated complicated congenital heart disease, such as hypoplastic left heart syndrome (HLHS), interruption of aortic arch (IAA), Shone Syndrome, moderate and severe mitral stenosis;
- History of known vasculopathy, genetic syndromes, diabetes mellitus, hyperlipoidemia or other cardiovascular risk factors.
Contacts and Locations
Contacts
| Contact: Yuan WANG, PhD | 86-010-64456169 | wangyuan980510@163.com | |
| Contact: Yan GU, PhD | 86-010-64456874 | echoguyan@163.com |
Locations
| China, Beijing | |
| Beijing Anzhen Hospital | Recruiting |
| Beijing, Beijing, China, 100029 | |
| Contact: Yuan WANG, PhD 86-010-64456169 wangyuan980510@163.com | |
| Contact: Yan GU, PhD 86-010-64456874 echoguyan@163.com | |
Sponsors and Collaborators
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Beijing Anzhen Hospital
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
Capital Institute of Pediatrics, China
Investigators
| Principal Investigator: | Jie DU, PhD | Beijing Institute of Heart, Lung and Blood Vessel Diseases |
| Tracking Information | |||||||||
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| First Submitted Date | July 4, 2019 | ||||||||
| First Posted Date | July 9, 2019 | ||||||||
| Last Update Posted Date | July 14, 2020 | ||||||||
| Actual Study Start Date | March 1, 2019 | ||||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Prognosis and Integrative Assessment of Aortic Coarctation Patients in China | ||||||||
| Official Title | Prognosis and Integrative Assessment of Aortic Coarctation Patients in CHINA | ||||||||
| Brief Summary | This is a systemic research of Chinese aortic coarctation patients, aiming to determine risk factors and serial biomarkers of aortic coarctation in prognosis. | ||||||||
| Detailed Description | 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. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Other |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA. If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid nitrogen.
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients with coarctation of the aorta, treated after 2002 in Beijing Anzhen Hospital. | ||||||||
| Condition | Coarctation of Aorta | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
300 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2023 | ||||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | up to 17 Years (Child) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04011956 | ||||||||
| Other Study ID Numbers | PICC | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Beijing Institute of Heart, Lung and Blood Vessel Diseases | ||||||||
| Study Sponsor | Beijing Institute of Heart, Lung and Blood Vessel Diseases | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Beijing Institute of Heart, Lung and Blood Vessel Diseases | ||||||||
| Verification Date | July 2020 | ||||||||
