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The 3q25 rs2305619 Polymorphism Associates With Microvascular Obstruction in STEMI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03907722
Recruitment Status : Completed
First Posted : April 9, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Surya Dharma, Indonesian Cardiovascular Research Center

Study Description
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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.

Condition or disease Intervention/treatment
STEMI Microvascular Coronary Artery Disease Other: Long pentraxin 3

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 217 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Month
Official Title: The 3q25 rs2305619 Polymorphism is Associated With Coronary Microvascular Obstruction Following Primary Angioplasty for Acute ST-segment Elevation Myocardial Infarction
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : August 2, 2018
Actual Study Completion Date : September 3, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
Genotypic variants
AA, AG and GG genotype
 Other: Long pentraxin 3
Primary PCI


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of microvascular obstruction [ Time Frame: Immediate after pci ]
    Percentage


Secondary Outcome Measures :
  1. Incidence of mortality [ Time Frame: 30 days ]
    Percentage


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with STEMI symptom onset <12h admitted to the ED and planned for primary PCI
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • STEMI patients who received fibrinolytic therapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907722


Locations
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Indonesia
Indonesian Cardiovascular Research Center
Jakarta, DKI Jakarta, Indonesia, 11420
Sponsors and Collaborators
Indonesian Cardiovascular Research Center
Investigators
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Principal Investigator: Surya Dharma, MD, PhD Indonesian Cardiovascular Center
More Information
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Additional Information:

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Responsible Party: Surya Dharma, Principal Investigator, Indonesian Cardiovascular Research Center
ClinicalTrials.gov Identifier: NCT03907722    
Other Study ID Numbers: IndonesianCRC2
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases