A Cohort of Patients Undergoing Percutaneous Coronary Int... | NCT05719545

Studies
A Cohort of Patients Undergoing Percutaneous Coronary Intervention

NCT05719545

Sponsor

Su Guohai

Status

Recruiting

Last Update Posted

Feb 9, 2023Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Acute Coronary Syndrome
Percutaneous Coronary Intervention
Myocardial Infarction
Unstable Angina

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 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Jan 31, 2023

First Submission Date that Met QC Criteria

Jan 31, 2023

First Posted Date

Feb 9, 2023Actual

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 31, 2023

Last Update Posted Date

Feb 9, 2023Actual

Name	Class
Shandong First Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To investigate the risk factors involved in the occurrence and prognosis of the patients with acute coronary syndrome, patients undergoing percutaneous coronary intervention will be recruited and followed up for at least 2 years.

Detailed Description

Patients with acute coronary syndrome undergoing percutaneous coronary intervention will be recruited and prospectively followed up for the incidence of major adverse cardiovascular events (MACE events), including all-cause mortality, cardiovascular mortality, ischemic stroke. Blood and fecal samples will be collected for further analysis. The basic and clinical information will be collected such as diagnosis, medical history, laboratory test results, therapy methods, prognosis and follow-up information. The risk factors involved in the occurrence and prognosis of acute coronary syndrome will be investigated.

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

10,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
major adverse cardiovascular events	all-cause mortality, cardiovascular mortality, ischemic stroke	2-year outcome and long-term outcome

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed as acute coronary syndrome and needed to undergo percutaneous coronary intervention.
>18 years old.

Exclusion Criteria:

With malignant tumors, acute infectious diseases and advanced liver diseases.
Won't sign an inform consent.

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

Patients with acute coronary syndrome undergoing percutaneous coronary intervention.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guohai Su, doctor	Contact	+86-18854125717		huangrong9277@163.com

Overall Officials

Name	Affiliation	Role
Guohao Su, doctor	Jinan Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinan Central Hospital	Recruiting	Jinan	Shandong		China

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome
D009203	Myocardial Infarction
D000789	Angina, Unstable

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided