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Immunomodulatory Therapy & VSA

D

Dao Wen Wang

Status

Completed

Conditions

Vasospastic Angina

Treatments

Drug: glucocorticosteroids and/or intravenous immunoglobulin

Study type

Observational

Funder types

Other

Identifiers

NCT06696807
TJ-IRB20211259

Details and patient eligibility

About

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.

Enrollment

71 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

71 participants in 2 patient groups

traditional therapy group
Description:
who received nitrate esters, CCBs, anti-platelet agents, and statins
immunomodulatory therapy group
Description:
who received glucocorticosteroids and/or IVIG in addition to traditional therapy.
Treatment:
Drug: glucocorticosteroids and/or intravenous immunoglobulin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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