Immunomodulatory Therapy & VSA

Completed

• Conditions: Vasospastic Angina
• Interventions: Drug: glucocorticosteroids and/or intravenous immunoglobulin

• Registration Number: NCT06696807
• Lead Sponsor: Dao Wen Wang

Brief Summary

Vasospastic angina (VSA) is caused by brief spasms of the main coronary artery and its major branches, resulting in varying degrees of luminal occlusion. Although vasodilator therapy is widely used and significantly alleviates VSA symptoms, it has not led to notable improvements in the prognosis of patients with VSA. Recent studies have suggested that inflammation plays a crucial role in VSA. This study aimed to evaluate the potential effectiveness of immunomodulatory therapy for improving patient prognosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-05-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-17
• Study First Submitted QC: 2024-11-17
• Last Update Submitted: 2024-11-17
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

(1) Transient total or subtotal occlusion of the coronary artery (contraction >90%) observed either spontaneously or in response to irritant stimulation (typically acetylcholine, ergot, or hyperventilation); (2) Presence or absence of ischemic electrocardiogram changes during episodes; (3) Nitrate-responsive angina during spontaneous episode: rest angina and/or marked diurnal variation in exercise tolerance and/or episodes precipitated by hyperventilation and/or suppression of episodes by calcium channel blockers.

Exclusion Criteria

(1) age 15 years or older; and (2) suspected VSA with chest pain and evidence of coronary spasm, or VSA diagnosed intraoperatively or at discharge.

The following exclusion criteria were applied: (1) failure to meet the diagnostic criteria for VSA; (2) presence of aortic disease, cardiomyopathy, malignant tumor, Kounis syndrome, or other diseases that may affect the outcome; (3) insufficient clinical data available; and (4) loss to follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
immunomodulatory therapy group	glucocorticosteroids and/or intravenous immunoglobulin	who received glucocorticosteroids and/or IVIG in addition to traditional therapy.

Primary Outcome Measures

Name	Time	Method
adverse outcomes	From Feb 2017 to Feb 2024	readmissions due to the onset of coronary spasm or VSA, MACE (including non-fatal stroke, non-fatal myocardial infarction, cardiovascular death) and all-cause death

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China