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Immunomodulatory Therapy & VSA

The Effects of Immunomodulatory Therapy in Patients with Vasospastic Angina

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06696807
Enrollment
71
Registered
2024-11-20
Start date
2018-10-01
Completion date
2024-05-01
Last updated
2024-11-20

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

Conditions

Vasospastic Angina

Keywords

Immunomodulatory therapy, vasospastic angina, Cohort Study

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.

Interventions

DRUGglucocorticosteroids and/or intravenous immunoglobulin

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

Sponsors

Dao Wen Wang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
adverse outcomesFrom Feb 2017 to Feb 2024readmissions due to the onset of coronary spasm or VSA, MACE (including non-fatal stroke, non-fatal myocardial infarction, cardiovascular death) and all-cause death

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026