Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	The change of manifestations of systemic symptom - fever	Through study completion, an average of 2 months.	The change of manifestations of systemic symptoms could effectively reflect the disease status of patients. The systemic symptoms associated with Takayasu arteritis mainly consist of fever, fatigue and chest congestion. Fever is examined by thermometer with the axillary's temperature, and the T\>37.5 degree is considered to be fever. After investigators excluding the fever caused by infection through CT or laboratory examinations, the occurrence of fever usually indicates the disease activity.
Primary	The change of manifestations of systemic symptom - fatigue	Through study completion, an average of 2 months.	The occurrence of fatigue indicates that the disease might be in the active phase. Self reported fatigue is obtained through inquiry, recorded by investigators and classified as "WITH" and "WITHOUT".
Primary	The change of manifestations of systemic symptoms - chest congestion	Through study completion, an average of 2 months.	The occurrence of chest congestion indicates that the heart and pulmonary might be involved and the disease might be in the active phase. Self reported chest congestion is obtained through inquiry, recorded by investigators and classified as "WITH" and "WITHOUT".
Primary	The change of the emerging signs or symptoms of ischemia	Through study completion, an average of 2 months.	Multiple emerging signs or symptoms could sensitively reflect the extent of ischemia of artery or organs. Self-reported emerging signs or symptoms of ischemia including vascular pain, dizziness, headache, amaurosis, vision loss, blurred vision, palpitations, chest pain, abdominal pain, claudication and other symptom through inquiry are recorded by investigators and classified as "WITH" and "WITHOUT". Participants with emerging signs or symptoms of ischemia usually face aggravating TA disease.
Primary	The change of the signs or symptoms of ischemia	Through study completion, an average of 2 months.	The vascular bruits and pulse strength are evaluated and scored from 0 to 2 (0=without bruits and pulse; 1=bruits and decreased pulse; 2= normal) by a special well-trained investigator. If the score decreases, the ischemia is exacerbated and classified as "WITH".
Primary	The change of the blood pressure	Through study completion, an average of 2 months.	The blood pressure change is measured with sphygmomanometer by the investigators. The measure is performed three times in each visit, and the mean systolic blood pressure (SBP) and mean diastolic blood pressure (DBP) are recorded. If the pressure fluctuates over 20mmHg, the stenosis of artery may exacerbate and the disease might be in the active phase.
Primary	The change of laboratory tests.	Through study completion, an average of 2 months.	The laboratory inflammatory markers such as erythrocyte sedimentation rate (ESR) are concise and efficient methods to monitor the change of disease status, and are examined by clinical laboratory in Zhongshan Hospital of Fudan University. Investigators record and summarize the results and evaluate the change of ESR under different treatment options.
Primary	The change of IL-6 in plasma	Through study completion, an average of 2 months.	IL-6 plays an important role in the progression of Takayasu arteritis. The level of plasma IL-6 is detected by clinical laboratory in Zhongshan Hospital of Fudan University. Investigators record and summarize the results and evaluate the change of IL-6 under different interventions, and analyze the relationship between IL-6 and disease status.
Primary	The change of vascular imaging.	Through study completion, an average of 2 months.	MRA and contrast-enhanced carotid ultrasound imaging are important methods to evaluate TA vascular inflammation and structural change. In the initial interview and every 3 times of follow-up, the imaging examination are carried out and the images are stored at the hospital. Two radiologists perform the independent reading and evaluation. Vascular imaging is employed to monitor the improvement of the vascular wall inflammation and vascular structures (including vessel wall thickness and vascular stenosis) during treatment. For patients with stent or other metallic foreign things in the body, PET-CT and CT are also used to examine the shape and lumen of the vessels.
Primary	The change of quality of life(QOF): SF-36 questionnaire	Through study completion, an average of 2 months.	The change of Quality of Life (QOF) with the SF-36 questionnaire Self reported the change of quality of life. Patients complete the SF-36 quality of life assessment questionnaire. Investigators provide the guidance and training on how to complete the questionnaire but must not interfere with the patients' own choice. Investigators evaluate the change of overall quality of life of patients and score the change from 0 to 2 (0= alleviated, 1=similar, 2= worsen).
Secondary	The change of obstetric related examinations in childbearing women.	From the initiation of pregnancy, 1 year.	For childbearing women who are preparing to be pregnant and being pregnant, investigators pay special attention to these participants and provide proper guidance and assistance promptly. To evaluate the change of obstetric related examinations, investigators record the results of obstetric related examinations such as height of uterus, abdominal perimeter, and collaborate with ultrasound specialist to perform the obstetric ultrasound to monitor the status of fetus. At last, investigators assess the process and scores from 0 to 4 with the help of doctors from gynecologist and obstetrician. (0= much better than normal women, 1= similar to normal women, 2= worse than normal women but without obstetrics and gynecology complications, 3= worse than normal women with obstetrics and gynecology complications, 4= abortion, death of fetus or mother.)

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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