The study of the intervention with statin on PE and CTEPH

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TNRC-08000263
• Date of registration: 2008-12-18
• Prospective Registration: No
• Primary sponsor: Tongji Hospital of Tongji University
• Public title: The study of the intervention with statin on PE and CTEPH
• Scientific title: The study of the intervention with statin on PE and CTEPH
• Date of first enrolment: 2008-06-01
• Target sample size: Group A:30;Group B:30;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=9265
• Study type: Observational study
• Study design: Non randomized control
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Haoming Song
• Affiliation: Tongji hospital of Tongji University

• Name: Haoming Song

Key inclusion & exclusion criteria

Inclusion criteria: 1. The diagnosis of the PE patients must meet 2 conditions of the followings:
(1) Selectivity pulmonary arteriography showes pulmonary artery obstruction or filling defect;
(2) Lung ventilation-perfusion scan manifests single or multiple blood perfusion defect, venting normal or unmoral, venting-dabble matchless;
(3) Clinical diagnosis: With risk factors for pulmonary embolism and clinical performance, electrocardiogram and chest film exclude other cardiovascular diseases and echocardiography, chest CT, blood gas analysis, D-dimer detection of combining support PTE diagnosis.
2. The diagnosis standard of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
(1)The mean pulmonary artery pressure is >=25mmHg ,while pulmonary capillary wedge pressure(PCWP)is normal (<=15mmHg);
(2) Lung ventilation-perfusion scan manifests single or multiple blood perfusion defect, venting normal or unmoral, venting-dabble matchless;
(3) Clinical diagnosis: With risk factors for pulmonary embolism or VTE history, clinical exertional dyspnea for more than six months, electrocardiogram and chest film exclude other cardiovascular diseases and echocardiography, chest CT, blood gas analysis, D-dimer detection of combining support PTE diagnosis.
Exclusion criteria: 1. With severe chronic obstructive pulmonary disease: FEV1/FVC<0.5;
2. Low-density lipoprotein cholesterol-C (LDL-C)<70mg/dl;
3. Patient refuse to take part in or can not co-operate the study;
4. With hemorrhagic diseases (such as active peptic ulcer disease, intracranial hemorrhage, trauma or other hemorrhagic diseases);
5. The level of serum transaminase is 3 times more than the normal limit; Or creatine kinase (CK) 5 times more than the normal limit;
6. With other severe heart diseases, as follows:
(1) Severe arrhythmia;
(2) Unstable Angina;
(3) Within six months after myocardial infarction;
(4) Cardiac function grade is IV (NYHA classification);
(5) Cerebrovascular diseases(such as transient ischemic attack, stroke) or other Cerebral arterial ischemia;
(6) Patients who is under 18 or older than 80;
(7) Patients with known drug sensitivity or drug allergy;
(8) Women who is in gestationperiod or lactation.

Age minimum: 18
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

pulmonary embolism and chronic thromboembolic pulmonary hypertension

Intervention(s)

Group A:basic treatment + atorvastatin;Group B:basic treatment;

Primary Outcome(s)

venous blood biochemical index (including liver enzyme, creatine kinase, etc);1) cardiac and pulmonary function classification; 2) six minute walking distance (6MWD); 3) echocardiograph;

Source(s) of Monetary Support

the study for Doctor's degree