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A clinical study of two-dimensional speckle tracking combined with ultrasonic pressure-strain loop technique in assessing the early impairment and prognosis of systemic lupus erythematosus-related right ventricular function

A clinical study of two-dimensional speckle tracking combined with ultrasonic pressure-strain loop technique in assessing the early impairment and prognosis of systemic lupus erythematosus-related right ventricular function

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300074215
Enrollment
Unknown
Registered
2023-08-01
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus erythematosus-associated cardiomyopathy

Interventions

Gold Standard:Clinical signs, hematological changes, immunological abnormalities, echocardiography, cardiac magnetic resonance imaging.
Index test:Two-dimensional speckle tracking technique and pressure-strain loop technique.

Sponsors

Second Affiliated Hospital of the People's Liberation Army Ground Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: nclusion criteria for systemic lupus erythematosus: 1) SLE patients aged 18 years or older, without gender limitation, 2) SLE patients who met the diagnostic criteria of European Federation of Rheumatology/American College of Rheumatology for systemic lupus erythematosus in 2019, and 3) SLE patients with normal right heart function (RVFAC =35% , Tei index =0.43, TAPSE =17 mm) who had not developed right heart failure by routine transthoracic echocardiography. 4) complete data of clinical cases, laboratory tests and examinations. 5) willing to participate in the study and sign the informed consent. The inclusion criteria in the control group were as follows: 1) adults over 18 years of age without gender limitation, 2) normal right ventricular function (RVFAC =35% , Tei index =0.43, TAPSE =17mm) , 3) normal blood and urine routine, normal liver and renal function, normal chest x-ray and ECG.

Exclusion criteria

Exclusion criteria: Exclusion criteria for systemic lupus erythematosus:1) patients with previous congenital heart defect, cardiomyopathy, valvular heart disease heart disease, coronary heart disease, chronic obstructive pulmonary disease, pulmonary embolism and other acute and chronic heart and lung diseases, 2) patients with poor image quality who could not obtain satisfactory tricuspid or pulmonary regurgitation spectrum, 3) patients who could not cooperate with the study for any reason or who were considered unsuitable for inclusion in the study. The exclusion criteria of the control group were: 1) having a history of heart disease and other diseases affecting the heart, such as hypertension, diabetes, renal vascular disease.

Design outcomes

Primary

MeasureTime frame
Anti-nuclear antibody;Anti-Sm antibody;longitudinal strain;myocardial work;right ventricular end diastolic diamete;right ventricular end systolic area;Right ventricular end-systolic area;Right ventricular area change fraction;Early diastolic peak velocity of tricuspid valve;Late diastolic peak flow velocity of tricuspid valve;Diastolic velocity of tricuspid valve annulus;Right atrial diastolic diameter;Peak systolic velocity of pulmonary artery;Rate of inferior vena cava collapse ;Sensitivity, SE;Specificity,SP;Positive predicative value, PPV;

Countries

China

Contacts

Public ContactXu Yali

Second Affiliated Hospital of the People's Liberation Army Ground Force Military Medical University

xuyali1976@163.com+86 185 2338 4936

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026