A Multi-Omics Study of Vasospastic Angina (KIVAM)

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.

Study Overview

• Status: Recruiting
• Conditions: Vasospastic Angina

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Yang Sun, MD, PhD; Email: sunyang.7@163.com
• Study Contact Backup: Name: Xin Xu, MD; Email: mambaout8@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: Yang Sun, MD, PhD; Phone Number: 86-27-83663280; Email: sunyang.7@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chinese patients with vasospastic angina

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy controls
Patients with acute myocardial infarction
Patients with vasospastic angina

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Death	Death from cardiovascular causes and any unknown death unless there was another certain cause	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	up to 48 months
Myocardial Infarction	The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction.	up to 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent angina	Recurrent angina	up to 48 months
Rehospitalization due to cardiovascular causes	Rehospitalization due to cardiovascular causes	up to 48 months

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina, Unstable; Angina Pectoris; Angina Pectoris, Variant
• Other Study ID Numbers: JTH-KIVAM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No