- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03907722
The 3q25 rs2305619 Polymorphism Associates With Microvascular Obstruction in STEMI
April 9, 2019 updated by: Surya Dharma, Indonesian Cardiovascular Research Center
The 3q25 rs2305619 Polymorphism is Associated With Coronary Microvascular Obstruction Following Primary Angioplasty for Acute ST-segment Elevation Myocardial Infarction
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators enrolled 217 patients with acute STEMI undergoing primary PCI in a tertiary care academic cardiovascular center.
The rs2305619 polymorphism was evaluated by real time PCR and plasma PTX3 concentration was assessed by human PTX3 ELISA kit.
The primary outcome of the study was the incidence of coronary microvascular obstruction defined as thrombolysis in myocardial infarction (TIMI) grade <3 flow after primary PCI or TIMI grade 3 flow with myocardial blush grade 0 or 1. Patients were grouped based on the genotypic variants (AA, AG and GG).
The primary outcome was compared among the three variants, as well as the PTX3 concentration and 30-day mortality.
Study Type
Observational
Enrollment (Actual)
217
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
-
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
Patients with STEMI symptom onset <12h admitted to the ED and planned for primary PCI
Description
Inclusion Criteria:
- Patients with acute STEMI with symptom onset <12 h and treated by primary PCI
Exclusion Criteria:
- 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
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Genotypic variants
AA, AG and GG genotype
|
Primary PCI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of microvascular obstruction
Time Frame: Immediate after pci
|
Percentage
|
Immediate after pci
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of mortality
Time Frame: 30 days
|
Percentage
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Surya Dharma, MD, PhD, Indonesian Cardiovascular Center
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 3, 2018
Study Registration Dates
First Submitted
April 5, 2019
First Submitted That Met QC Criteria
April 5, 2019
First Posted (Actual)
April 9, 2019
Study Record Updates
Last Update Posted (Actual)
April 11, 2019
Last Update Submitted That Met QC Criteria
April 9, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IndonesianCRC2
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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