Vasospastic AnginaKIVAMNCT05282511
A Multi-Omics Study of Vasospastic Angina
An observational study of Vasospastic Angina, run by Tongji Hospital at 1 site in China.
Trial summary
This is a observational study to identify the key factor associated with vasospastic angina and to explore the prognosis of the participants. The study will recruit 400 patients with vasospastic angina, 400 healthy controls and 400 patients with acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vasospastic Angina
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese patients with vasospastic angina
Who may be able to join
- 18 years of age or older
- diagnosed as vasospastic angina
Who cannot join
- participate in any drug clinical trials within 3 months
- patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years
- serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients)
- previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix)
Trial locations and contacts
1 site in 1 country.
Yang Sun, MD, PhD contact
Xin Xu, MD contact
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Yang Sun, MD, PhD, 86-27-83663280, sunyang.7@163.com
About this study
Official title: Identification of the Key Factors Increasing the Risk of Vasospastic Angina Based on Multi-omics.
This is a observational study to identify the key factor associated with vasospastic angina and to explore the prognosis of the participants. The study will recruit 400 patients with vasospastic angina, 400 healthy controls and 400 patients with acute myocardial infarction. Next generation sequencing, metabolome and proteomics will be performed in these participants.
- Conditions
- Vasospastic Angina
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute myocardial infarction | Patients with acute myocardial infarction | |
| Healthy controls | Healthy controls | |
| Patients with vasospastic angina | Patients with vasospastic angina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Death
Death from cardiovascular causes and any unknown death unless there was another certain cause
Measured: up to 48 months
Stroke
A rapid onset of a new focal loss of neurologic function caused by an ischemic central nervous system event with residual symptoms lasting at least 24 hours from their onset or leading to death
Measured: up to 48 months
Myocardial Infarction
The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction.
Measured: up to 48 months
Secondary outcomes (2)
Recurrent angina
Recurrent angina
Measured: up to 48 months
Rehospitalization due to cardiovascular causes
Rehospitalization due to cardiovascular causes
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study startJan 2012
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
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
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dao Wen Wang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282511
- Sponsor's protocol ID
- JTH-KIVAM
- Acronym
- KIVAM
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Key Factors Increasing the Risk of Vasospastic Angina Based on Multi-omics.
- ClinicalTrials.gov ID
- NCT05282511
- Acronym / sponsor ID
- KIVAM / JTH-KIVAM
- Conditions
- Vasospastic Angina
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Mar 2022 (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.
This is a observational study to identify the key factor associated with vasospastic angina and to explore the prognosis of the participants. The study will recruit 400 patients with vasospastic angina, 400 healthy controls and 400 patients with acute myocardial infarction. Next generation sequencing, metabolome and proteomics will be performed in these participants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with acute myocardial infarction | – | –Patients with acute myocardial infarction |
| Healthy controls | – | –Healthy controls |
| Patients with vasospastic angina | – | –Patients with vasospastic angina |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients with vasospastic angina
Key inclusion criteria (2 listed)
- 18 years of age or older
- diagnosed as vasospastic angina
Key exclusion criteria (4 listed)
- participate in any drug clinical trials within 3 months
- patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years
- serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients)
- previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular Death
Time frame: up to 48 months
Death from cardiovascular causes and any unknown death unless there was another certain cause
Stroke
Time frame: up to 48 months
A rapid onset of a new focal loss of neurologic function caused by an ischemic central nervous system event with residual symptoms lasting at least 24 hours from their onset or leading to death
Myocardial Infarction
Time frame: up to 48 months
The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction.
2 secondary outcomes
Recurrent angina
Time frame: up to 48 months
Rehospitalization due to cardiovascular causes
Time frame: up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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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.
Yang Sun, MD, PhD contact
Xin Xu, MD contact
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 Tongji Hospital 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Sun, MD, PhD (sunyang.7@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Death (time frame: up to 48 months). The study lists 3 primary outcomes in all. 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 16 Mar 2022.