Immunomodulatory Therapy & VSA

NCT ID: NCT06696807

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2024-05-01

Brief Summary

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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

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Conditions

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Vasospastic Angina

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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traditional therapy group

who received nitrate esters, CCBs, anti-platelet agents, and statins

No interventions assigned to this group

immunomodulatory therapy group

who received glucocorticosteroids and/or IVIG in addition to traditional therapy.

glucocorticosteroids and/or intravenous immunoglobulin

Intervention Type DRUG

methylprednisolone: 20-200mg/day intravenous immunoglobulin: 5-20 g/day

Interventions

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glucocorticosteroids and/or intravenous immunoglobulin

methylprednisolone: 20-200mg/day intravenous immunoglobulin: 5-20 g/day

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dao Wen Wang

OTHER

Sponsor Role lead

Responsible Party

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Dao Wen Wang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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TJ-IRB20211259

Identifier Type: -

Identifier Source: org_study_id

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