- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03894176
Association of Plasma PTX3 Concentration and Outcomes of STEMI
March 26, 2019 updated by: Surya Dharma, Indonesian Cardiovascular Research Center
Association of Plasma Pentraxin 3 Concentration With Angiographic and Clinical Outcomes in STEMI Treated by Primary Angioplasty
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
335
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia, 11420
- Indonesian Cardiovascular Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients with STEMI with symptom onset <12 h who admiited to the emergency department and planned for primary PCI.
Description
Inclusion Criteria:
- Patients with acute STEMI with symptom onset <12 h undergoing primary PCI
Exclusion Criteria:
- Acute STEMI patients who received fibrinolytic therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PTX3 concentration
First quartile, second quartile, third quartile and fourth quartile of PTX3 in ng/mL
|
Long pentraxin 3, thrombus burden, final TIMI flow, ST segment resolution, STEMI, primary PCI
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of thrombus grade 4&5 and final TIMI flow <3
Time Frame: Intraprocedure
|
PTX3 concentration was compared based on the outcome
|
Intraprocedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
August 2, 2018
Study Completion (Actual)
September 2, 2018
Study Registration Dates
First Submitted
March 26, 2019
First Submitted That Met QC Criteria
March 26, 2019
First Posted (Actual)
March 28, 2019
Study Record Updates
Last Update Posted (Actual)
March 28, 2019
Last Update Submitted That Met QC Criteria
March 26, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IndonesianCRC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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