Association of Plasma PTX3 Concentration and Outcomes of... | NCT03894176

Studies
Association of Plasma PTX3 Concentration and Outcomes of STEMI

NCT03894176

Sponsor

Indonesian Cardiovascular Research Center

Status

Completed

Last Update Posted

Mar 28, 2019Actual

Enrollment

335Actual

Phase

Not provided

Conditions

STEMI
Coronary; Ischemic

Interventions

Plasma PTX3 concentration

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

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Aug 2, 2018Actual

Completion Date

Sep 2, 2018Actual

First Submitted Date

Mar 26, 2019

First Submission Date that Met QC Criteria

Mar 26, 2019

First Posted Date

Mar 28, 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

Mar 26, 2019

Last Update Posted Date

Mar 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Surya Dharma, Primary Investigator, Indonesian Cardiovascular Research CenterPrincipal Investigator

Lead Sponsor

Indonesian Cardiovascular Research CenterOTHER

Collaborators

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

335 of patients with STEMI treated by primary PCI were assayed for PTX3 measurement by ELISA method. The angiographic and clinical outcomes were evaluated according to the PTX3 concentration.

Detailed Description

335 of patients with STEMI treated by primary PCI were assayed for PTX3 measurement by ELISA method using human PTX3 kit. Blood was drawn at the emergency department before primary PCI. The angiographic and clinical outcomes were evaluated and analyzed according to the PTX3 concentration. The angiographic outcome were thrombus grade on initial angiogram and final TIMI flow. The clinical outcome were ECG resolution after primary PCI and all-cause death at 30 days. The plasma PTX3 concentration was then compared based on the outcomes.

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

335Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PTX3 concentration		First quartile, second quartile, third quartile and fourth quartile of PTX3 in ng/mL	Other: Plasma PTX3 concentration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plasma PTX3 concentration	Other	Long pentraxin 3, thrombus burden, final TIMI flow, ST segment resolution, STEMI, primary PCI	PTX3 concentration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of thrombus grade 4&5 and final TIMI flow <3	PTX3 concentration was compared based on the outcome	Intraprocedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with acute STEMI with symptom onset <12 h undergoing primary PCI

Exclusion Criteria:

Acute STEMI patients who received fibrinolytic therapy

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

All patients with STEMI with symptom onset <12 h who admiited to the emergency department and planned for primary PCI.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indonesian Cardiovascular Research Center		Jakarta	DKI Jakarta	11420	Indonesia

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
D000072657	ST Elevation Myocardial Infarction
D007511	Ischemia

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided