Jakarta Acute Coronary Syndrome Registry | NCT02319473

Studies
Jakarta Acute Coronary Syndrome Registry

NCT02319473

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Status

Unknown status

Last Update Posted

May 5, 2017Actual

Enrollment

28,812Estimated

Phase

Not provided

Conditions

Acute Coronary Syndrome

Interventions

JAC Registry

Countries

Indonesia

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

May 2017

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 2007

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Dec 15, 2014

First Submission Date that Met QC Criteria

Dec 17, 2014

First Posted Date

Dec 18, 2014Estimated

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

May 3, 2017

Last Update Posted Date

May 5, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Surya Dharma, MD, PhD, Jakarta Acute Coronary Syndrome Registry, National Cardiovascular Center Harapan Kita Hospital IndonesiaPrincipal Investigator

Lead Sponsor

National Cardiovascular Center Harapan Kita Hospital IndonesiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Jakarta acute coronary syndrome enrolled patients with acute coronary syndrome admitted to the emergency department of all health centers in Jakarta and the surrounding area.

Detailed Description

The JAC registry is an ongoing prospective, multi center, observational study that aims to enroll ACS patients who admitted to the emergency department (ED) of all health centers in Jakarta and the surrounding area. The registry has been collecting data since 2007, and used extensively since 2014.

Currently, the JAC registry is the main source of data for measuring the performance of the STEMI network in the region, namely Jakarta Cardiovascular Care Unit Network System. The STEMI network in Jakarta has been introduced as an integral part of the government project since 2010/2011.

STEMI was diagnosed based on the typical chest pain and ST segment elevation on two or more contiguos leads. The number of primary PCI, fibrinolytic therapy and non-reperfused patients were recorded.

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

No data available

No data is available for this block.

Enrollment

28,812Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JAC Registry	Other	patients who received acute reperfusion therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of primary PCI		15 years
In-hospital mortality		15 years

Secondary Outcomes

Measure	Description	Time Frame
The number of fibrinolytic therapy		15 years
The number of non-reperfused patients		15 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

STEMI patients that was diagnosed based on the presence of typical chest pain and ST-segment elevation in two or more contigious leads on the initial ECG

Exclusion Criteria:

STEMI patients that was under 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

All acute coronary syndrome patients admitted to the emergency department.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Surya Dharma, MD, PhD	Contact	+62215684085	5002	drsuryadharma@yahoo.com
Ade Priyanto	Contact	+62215684085	5002	adepriyanto2003@yahoo.com

Overall Officials

Name	Affiliation	Role
Surya Dharma, MD, PhD	National Cardiovascular Center Harapan Kita	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cardiovascular Center Harapan Kita	Recruiting	Jakarta		11420	Indonesia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27580835	Background	Dharma S, Andriantoro H, Purnawan I, Dakota I, Basalamah F, Hartono B, Rasmin R, Isnanijah H, Yamin M, Wijaya IP, Pratama V, Gunarto TB, Juwana YB, Suling FR, Witjaksono AM, Lasanudin HF, Iskandarsyah K, Priatna H, Tedjasukmana P, Wahyumandradi U, Kosasih A, Budhiarti IA, Pribadi W, Wirianta J, Lubiantoro U, Pramesti R, Widowati DR, Aminda SK, Basalamah MA, Rao SV. Characteristics, treatment and in-hospital outcomes of patients with STEMI in a metropolitan area of a developing country: an initial report of the extended Jakarta Acute Coronary Syndrome registry. BMJ Open. 2016 Aug 31;6(8):e012193. doi: 10.1136/bmjopen-2016-012193.
26019883

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