NCT04239404

Brief Summary

This is a single-center, observational, prospective study. This study aims to observe the effect of periprocedural myocardial injury on cardiovascular events in patients undergoing elective percutaneous coronary intervention, and to detect the levels of serum inflammatory factors before and after intervention to predict the occurrence of periprocedural myocardial injury and its association with cardiovascular events.

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

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, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3.9 years

First QC Date

January 20, 2020

Last Update Submit

January 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Major cardiac events

    cardiac death, target vessel revascularization, target lesion revascularization, non-fatal myocardial infarction, heart failure, angina pectoris

    12 months after PCI

Secondary Outcomes (1)

  • Serum level of inflammatory factors

    1 day after PCI

Study Arms (2)

PMI

non-PMI

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In-patients with stable coronary artery disease undergoing elective percutaneous coronary intervention in Zhongshan Hospital will be enrolled.

You may qualify if:

  • underwent elective coronary stenting
  • patients permit informed consents

You may not qualify if:

  • acute STEMI
  • NYHA class III-IV heart failure
  • moderate-to-severe valvular disease
  • missing post-PCI troponin results
  • active infection, respiratory failure
  • liver dysfunction (liver enzyme \>3xURL or bilirubin \>2xURL),
  • malignancy and systemic connective tissue disease
  • unable to get a informed consents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples of the participants before and after percutaneous coronary intervention therapy were selected.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 27, 2020

Study Start

January 1, 2017

Primary Completion

December 1, 2020

Study Completion

May 1, 2021

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations