Vasospastic AnginaNCT06696807
Immunomodulatory Therapy & VSA
An observational study of Vasospastic Angina, run by Dao Wen Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Vasospastic Angina
- What is being tested?
- glucocorticosteroids and/or intravenous immunoglobulin
- Type of treatment
- Injection or infusion
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vasospastic Angina
- Being tested
- glucocorticosteroids and/or intravenous immunoglobulin
- Keywords
- Immunomodulatory therapy, vasospastic angina, Cohort Study
- Medical subject headings
- Angina Pectoris, Variant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucocorticosteroids and/or intravenous immunoglobulinDrug
methylprednisolone: 20-200mg/day intravenous immunoglobulin: 5-20 g/day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: glucocorticosteroids and/or intravenous immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Feb 2017 to Feb 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Oct 2018
- Primary completion1 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasospastic AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dao Wen Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dao Wen Wang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696807
- Sponsor's protocol ID
- TJ-IRB20211259
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are working hard to have IPD sharing plan and are willing to share it with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Immunomodulatory Therapy in Patients with Vasospastic Angina
- ClinicalTrials.gov ID
- NCT06696807
- Acronym / sponsor ID
- TJ-IRB20211259
- Conditions
- Vasospastic Angina
- Keywords
- Immunomodulatory therapy, vasospastic angina, Cohort Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Dao Wen WangUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional therapy group | – | –who received nitrate esters, CCBs, anti-platelet agents, and statins |
| immunomodulatory therapy group | – | Drug: glucocorticosteroids and/or intravenous immunoglobulinwho received glucocorticosteroids and/or IVIG in addition to traditional therapy. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glucocorticosteroids and/or intravenous immunoglobulinmethylprednisolone: 20-200mg/day intravenous immunoglobulin: 5-20 g/day | Drug | immunomodulatory therapy group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: Undecided. We are working hard to have IPD sharing plan and are willing to share it with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasospastic Angina, run by Dao Wen Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse outcomes (time frame: From Feb 2017 to Feb 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.