NCT03907722

Brief Summary

The investigators enrolled 217 patients with acute STEMI undergoing primary PCI. The rs2305619 polymorphism was evaluated by real time PCR and plasma PTX3 concentration was assessed by human PTX3 ELISA kit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
217

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 3, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

April 5, 2019

Last Update Submit

April 9, 2019

Conditions

STEMIMicrovascular Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Incidence of microvascular obstruction

    Percentage

    Immediate after pci

Secondary Outcomes (1)

  • Incidence of mortality

    30 days

Study Arms (1)

Genotypic variants

AA, AG and GG genotype

Other: Long pentraxin 3

Interventions

Long pentraxin 3OTHER

Primary PCI

Genotypic variants

Eligibility Criteria

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

Patients with STEMI symptom onset \<12h admitted to the ED and planned for primary PCI

You may qualify if:

  • Patients with acute STEMI with symptom onset \<12 h and treated by primary PCI

You may not qualify if:

  • 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 Infarction

Interventions

PTX3 protein

Condition Hierarchy (Ancestors)

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

Study Officials

  • Surya Dharma, MD, PhD

    Indonesian Cardiovascular Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 9, 2019

Study Start

January 1, 2018

Primary Completion

August 2, 2018

Study Completion

September 3, 2018

Last Updated

April 11, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)