Registry Study of Pharmacotherapy and Clinical Outcomes i... | NCT05246722

Studies
Registry Study of Pharmacotherapy and Clinical Outcomes in Elderly Patients With Coronary Heart Disease (PHARM-ageing)

NCT05246722

Sponsor

Beijing Anzhen Hospital

Status

Unknown status

Last Update Posted

Feb 18, 2022Actual

Enrollment

15,000Estimated

Phase

Not provided

Conditions

Elderly Patients
Coronary Heart Disease
Drug Therapy
Clinical Outcomes

Interventions

Not provided

Countries

Not provided

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

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2022Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Jan 13, 2022

First Submission Date that Met QC Criteria

Feb 9, 2022

First Posted Date

Feb 18, 2022Actual

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

Feb 9, 2022

Last Update Posted Date

Feb 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lin Yang, Director of pharmacy department of Beijing Anzhen Hospital, Beijing Anzhen HospitalPrincipal Investigator

Lead Sponsor

Beijing Anzhen HospitalOTHER

Collaborators

Not provided

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
main adverse cardiovascular and cerebrovascular events (MACCE)	MACCE will be defined as all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemic-driven revascularization	up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
Adverse drug reaction	Adverse drug reaction will be defined as any adverse reactions in the patients	up to 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent has been signed
Patients diagnosed in our hospital with coronary heart disease
Age ≥65 years

Exclusion Criteria:

Severe lack of important information such as history of previous medication, history of previous disease, history of surgery.
Mental disorders, or inability to communicate effectively with researchers, or failure to comply with research protocols.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Elderly patients (≥65 years) with coronary heart disease who discharged at Beijing Anzhen Hospital from January 1, 2019.Those who fill the inclusion criteria at screening will be invited for the registry study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yunnan Zhang, PhD	Contact	86-010-64456609		zhangyn125@yeah.net
Yang Lin, PhD	Contact	86-010-64456609		linyang3623@outlook.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided