NCT05282511

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

10.9 years

First QC Date

March 7, 2022

Last Update Submit

March 7, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Recurrent angina

    up to 48 months

  • Rehospitalization due to cardiovascular causes

    up to 48 months

Study Arms (3)

Patients with acute myocardial infarction

Patients with acute myocardial infarction

Healthy controls

Healthy controls

Patients with vasospastic angina

Patients with vasospastic angina

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese patients with vasospastic angina

You may qualify if:

  • years of age or older
  • diagnosed as vasospastic angina

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Blood Cells and DNA

MeSH Terms

Conditions

Angina Pectoris, Variant

Condition Hierarchy (Ancestors)

Angina, UnstableAngina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Yang Sun, MD, PhD

CONTACT

Xin Xu, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 16, 2022

Study Start

January 1, 2012

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations