A Multi-Omics Study of Vasospastic Angina

Vasospastic Angina Clinical Trial

— KIVAM  

Official title:

Identification of the Key Factors Increasing the Risk of Vasospastic Angina Based on Multi-omics.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05282511
• Other study ID #: JTH-KIVAM
• Status: Recruiting
• Start date: January 2012
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: Tongji Hospital
• Contact: Yang Sun, MD, PhD
• Email: sunyang.7[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Next generation sequencing, metabolome and proteomics will be performed in these participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• diagnosed as vasospastic angina

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Variant
• Vasospastic Angina

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Death	Death from cardiovascular causes and any unknown death unless there was another certain cause	up to 48 months
Primary	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	up to 48 months
Primary	Myocardial Infarction	The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction.	up to 48 months
Secondary	Recurrent angina	Recurrent angina	up to 48 months
Secondary	Rehospitalization due to cardiovascular causes	Rehospitalization due to cardiovascular causes	up to 48 months