Essen Coronary Artery Disease Registry | NCT04196712

Studies
Essen Coronary Artery Disease Registry

NCT04196712

Sponsor

University Hospital, Essen

Status

Recruiting

Last Update Posted

Dec 24, 2024Actual

Enrollment

55,000Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

Germany

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

Dec 2024

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

Sep 1, 2019Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Dec 5, 2019

First Submission Date that Met QC Criteria

Dec 10, 2019

First Posted Date

Dec 12, 2019Actual

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

Dec 18, 2024

Last Update Posted Date

Dec 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The ECAD registry is a registry of patients undergoing coronary angiography at the West German Heart and Vascular Center. The registry anticipates to determine predictors of patient outcome after coronary angiography.

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

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

55,000Estimated

Label	Type	Description	Intervention Names
Coronary angiography arm		Patient undergoing invasive coronary angiography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality	Mortality of any cause	through study completion, an average of 3 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing invasive coronary angiography at the West German Heart and Vascular Center

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

This registry includes all consecutive patients undergoing invasive coronary angiography at the West German Heart and Vascular Center, starting from 2003.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amir A Mahabadi, MD	Contact	+49 201 723	84822	amir-abbas.mahabadi@uk-essen.de
Matthias Totzeck, MD	Contact	+49 201 723	84805	matthias.totzeck@uk-essen.de

Overall Officials

Name	Affiliation	Role
Tienush Rassaf, MD	University Hospital Essen, Deparment of Cardiology and Vascular Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Essen	Recruiting	Essen	North Rhine-Westphalia	45147	Germany

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