Prognostic Impact of PMI in Stable CAD Undergoing PCI | NCT04239404

Studies
Prognostic Impact of PMI in Stable CAD Undergoing PCI

NCT04239404

Sponsor

Shanghai Zhongshan Hospital

Status

Unknown status

Last Update Posted

Jan 27, 2020Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Periprocedural Myocardial Injury
Coronary Artery Disease
Percutaneous Coronary Intervention

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

May 2021Estimated

First Submitted Date

Jan 20, 2020

First Submission Date that Met QC Criteria

Jan 20, 2020

First Posted Date

Jan 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2020

Last Update Posted Date

Jan 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Serum level of inflammatory factors	Serum level of inflammatory factors including TNFα, IL-6 and so on.	1 day after PCI

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

underwent elective coronary stenting
patients permit informed consents

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhangwei Chen, MD	Contact	+86 21 64041990		chen.zhangwei@zs-hospital.sh.cn
Danbo Lu, PhD	Contact	+86 21 64041990		lu.danbo@zs-hospital.sh.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
180 Fenglin Road	Recruiting	Shanghai	Shanghai Municipality	200032	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided