Immunomodulatory Therapy & VSA

NCT06696807 | Completed

• 1 other identifier: TJ-IRB20211259
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Vasospastic Angina

Keywords

Immunomodulatory therapy; vasospastic angina; Cohort Study

Outcome Measures

Primary Outcomes (1)

• adverse outcomes

  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

  From Feb 2017 to Feb 2024

Study Arms (2)

traditional therapy group

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

immunomodulatory therapy group

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

Drug: glucocorticosteroids and/or intravenous immunoglobulin

Interventions

glucocorticosteroids and/or intravenous immunoglobulin DRUG

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

immunomodulatory therapy group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

160 participants with suspected VSA between October 2018 and April 2024 were selected. After the screening process, 71 participants were included in the analysis. The participants were divided into two groups according to the treatment received, with 50 and 21 participants in the traditional and immunomodulatory therapy groups, respectively.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Dao Wen Wang: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Angina Pectoris, Variant

Condition Hierarchy (Ancestors)

Angina, Unstable; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 20, 2024
• Study Start: October 1, 2018
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

CN (1)