Risk Factor Assessment for Acute Pulmonary Hypertension Crisis
Research on the Clinical Risk Factor Assessment System for Acute Pulmonary Hypertension Crisis and Its Mortality
The goal of this observational study is to learn about pulmonary hypertension crisis (PHC) - a severe, and often fatal complication - in patients with pulmonary hypertension (PH). The main questions this study aims to answer are:
What are the clinical and hemodynamic features of PHC, and what underlying pathophysiological mechanisms cause it to develop? Can these features be used to diagnostic PHC, predict who is at risk of developing it or dying from it, and develop targeted prevention and treatment of PHC?
A multi-center registry platform and biobank will be established to enroll and follow up patients with PH. Clinical data, hemodynamic measurements, and biological specimen will be collected. Risk prediction and early warning tools of PHC will be developed.
연구 개요
상태
상세 설명
Pulmonary hypertension crisis (PHC) is a severe and fatal complication of pulmonary hypertension (PH), characterized by the sudden elevation of pulmonary vascular resistance, acute right hear failure and collapse of systemic circulation. However, PHC currently lacks any internationally accepted definition or diagnostic criteria, and it is still unclear which are the clinical, pathophysiological and molecular risk factors of PHC.
This study aims to establish a large clinical cohort of patients with PH, validate the definition of PHC, identify risk factors of PHC occurrence and mortality, and develop tools for the risk-prediction and early-warning of PHC.
This is a multi-center, prospective cohort study with a retrospective component for model training. Following national health-information standards, a standardized registry dataset will be established to cover demographics, clinical features, laboratory tests, imaging, and hemodynamic profile. Existing PH cohort databases will be integrated and expanded to a target of 5,000 patients. A subset of cases with right heart catheter parameters (RHC) will be extracted. A multi-center biospecimen management platform will be established.
For PHC onset, the investigators will assemble a clinical-molecular-imaging feature set and use convolutional neural networks and tree-based algorithms for feature extraction, then build a cross-modal prediction model using multi-task learning, neural networks, and a Transformer architecture. The model will be prospectively validated and tuned against real-world performance. For PHC mortality, models will be built on patients meeting the new PHC criteria, using 28-day attributable death, all-cause death, and long-term death as endpoints. Models will be trained on a retrospective cohort and then evaluated for accuracy and generalizability on both an internal validation set and an external prospective-cohort validation set.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Run Dong, MD
- 전화번호: 861069155036
- 이메일: dongrun5858@foxmail.com
연구 장소
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Beijing, 중국, 100730
- Peking Union Medical College Hospital
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연락하다:
- Run Dong
- 전화번호: +86 10 69155036
- 이메일: dongrun5858@foxmail.com
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수석 연구원:
- Jinmin Peng, MD
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Shanghai, 중국
- Shanghai Pulmonary Hospital
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연락하다:
- Wenhui Wu, MD
- 전화번호: +86 21 65115006
- 이메일: wenhui5621006@126.com
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Guangdong
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Guangzhou, Guangdong, 중국
- Guangdong Province People's Hospital
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연락하다:
- Xianmei Li, MD
- 전화번호: +86 20 8382 7812
- 이메일: lixianmei@gdph.org.cn
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Yunnan
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Kunming, Yunnan, 중국
- Yan'an Affiliated Hospital of Kunming Medical University
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연락하다:
- Hailong Dai, MD
- 전화번호: +86 0871 63211157
- 이메일: dhlkm@qq.com
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Pulmonary hypertension confirmed by mean pulmonary arterial pressure (mPAP) over 20 mmHg measured by right heart catheter
- At least once per year of follow-up data collection record
Exclusion Criteria:
- Patients with missing baseline or follow-up data
- Complicated by other diseases with significant influence on survival, such as acute coronary syndrome, malignancy, etc.
- Complicated by other diseases with significant influence on hemodynamics, such as sepsis, acute left heart failure, and acute pulmonary embolism, etc.
- Receiving medications with significant influence on hemodynamics
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Pulmonary hypertension
Patients with right heart catheter confirmed pulmonary hypertension
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pulmonary hypertension crisis
기간: From enrollment to 3 years after enrollment
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Critical increase of pulmonary vascular resistance accompanied by right heart dysfunction and systemic hypoperfusion
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From enrollment to 3 years after enrollment
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28 day mortality attributed to pulmonary hypertension crisis
기간: From hospitalization to 28 days
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Death attributed to pulmonary hypertension crisis within 28 days of hospitalization
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From hospitalization to 28 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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All cause mortality within hospitalization
기간: From hospitalization to discharge or documented death, whichever is earlier, assessed up to 3 years
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All cause death within hospitalization
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From hospitalization to discharge or documented death, whichever is earlier, assessed up to 3 years
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All cause mortality within 3 years
기간: From the diagnosis of pulmonary hypertension crisis to documented death, assessed up to 3 years
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All cause death within 3 years from the diagnosis of pulmonary hypertension crisis
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From the diagnosis of pulmonary hypertension crisis to documented death, assessed up to 3 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jinmin Peng, MD, Peking Union Medical College Hospital
간행물 및 유용한 링크
일반 간행물
- Qian J, Li M, Zhang X, Wang Q, Zhao J, Tian Z, Wei W, Zuo X, Zhang M, Zhu P, Ye S, Zhang W, Zheng Y, Qi W, Li Y, Zhang Z, Ding F, Gu J, Liu Y, Wang Y, Zeng X; following investigators were collaborators in the CSTAR-PAH study:. Long-term prognosis of patients with systemic lupus erythematosus-associated pulmonary arterial hypertension: CSTAR-PAH cohort study. Eur Respir J. 2019 Feb 14;53(2):1800081. doi: 10.1183/13993003.00081-2018. Print 2019 Feb.
- Hemnes AR, Beck GJ, Newman JH, Abidov A, Aldred MA, Barnard J, Berman Rosenzweig E, Borlaug BA, Chung WK, Comhair SAA, Erzurum SC, Frantz RP, Gray MP, Grunig G, Hassoun PM, Hill NS, Horn EM, Hu B, Lempel JK, Maron BA, Mathai SC, Olman MA, Rischard FP, Systrom DM, Tang WHW, Waxman AB, Xiao L, Yuan JX, Leopold JA; PVDOMICS Study Group. PVDOMICS: A Multi-Center Study to Improve Understanding of Pulmonary Vascular Disease Through Phenomics. Circ Res. 2017 Oct 27;121(10):1136-1139. doi: 10.1161/CIRCRESAHA.117.311737.
- Qu J, Li M, Zhang X, Zhang M, Zuo X, Zhu P, Ye S, Zhang W, Zheng Y, Qi W, Li Y, Zhang Z, Ding F, Gu J, Liu Y, Qian J, Huang C, Zhao J, Wang Q, Liu Y, Tian Z, Wang Y, Wei W, Zeng X. A prognostic model for systemic lupus erythematosus-associated pulmonary arterial hypertension: CSTAR-PAH cohort study. Respir Res. 2023 Sep 9;24(1):220. doi: 10.1186/s12931-023-02522-2.
- Boucly A, Song S, Keles M, Wang D, Howard LS, Humbert M, Sitbon O, Lawrie A, Thompson AAR, Frank P, Kivimaki M, Rhodes CJ, Wilkins MR. Clustering Patients with Pulmonary Hypertension Using the Plasma Proteome. Am J Respir Crit Care Med. 2025 Aug;211(8):1492-1503. doi: 10.1164/rccm.202408-1574OC.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- K7949
- 2024ZD0526701 (기타 보조금/기금 번호: Ministry of Science and Technology of the People's Republic of China)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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폐 고혈압에 대한 임상 시험
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University of Colorado, Denver모집하지 않고 적극적으로단심실 | 폐 혈관 저항 이상 | 대사체학 | 우수한 Cavo-Pulmonary 문합 | 엔도텔린미국