NCT03894176

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

March 26, 2019

Last Update Submit

March 26, 2019

Conditions

STEMICoronary; Ischemic

Outcome Measures

Primary Outcomes (1)

  • The proportion of thrombus grade 4&5 and final TIMI flow <3

    PTX3 concentration was compared based on the outcome

    Intraprocedure

Study Arms (1)

PTX3 concentration

First quartile, second quartile, third quartile and fourth quartile of PTX3 in ng/mL

Other: Plasma PTX3 concentration

Interventions

Plasma PTX3 concentrationOTHER

Long pentraxin 3, thrombus burden, final TIMI flow, ST segment resolution, STEMI, primary PCI

Also known as: PTX3
PTX3 concentration

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Acute STEMI patients who received fibrinolytic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indonesian Cardiovascular Research Center

Jakarta, DKI Jakarta, 11420, Indonesia

Location

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionIschemia

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

March 26, 2019

First Posted

March 28, 2019

Study Start

January 1, 2018

Primary Completion

August 2, 2018

Study Completion

September 2, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)