Immunomodulatory Therapy & VSA

November 17, 2024 updated by: Dao Wen Wang

The Effects of Immunomodulatory Therapy in Patients with Vasospastic Angina

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
methylprednisolone: 20-200mg/day intravenous immunoglobulin: 5-20 g/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse outcomes
Time Frame: 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
From Feb 2017 to Feb 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dao Wen Wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

November 17, 2024

First Submitted That Met QC Criteria

November 17, 2024

First Posted (Estimated)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 17, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB20211259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We are working hard to have IPD sharing plan and are willing to share it with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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