STEMINCT03907722
The 3q25 rs2305619 Polymorphism Associates With Microvascular Obstruction in STEMI
An observational study of STEMI and Microvascular Coronary Artery Disease, run by Indonesian Cardiovascular Research Center at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- STEMI, Microvascular Coronary Artery Disease
- What is being tested?
- Long pentraxin 3
- How many people
- 217 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2018to 3 Sep 2018
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with STEMI symptom onset <12h admitted to the ED and planned for primary PCI
Who may be able to join
- Patients with acute STEMI with symptom onset <12 h and treated by primary PCI
Who cannot join
- STEMI patients who received fibrinolytic therapy
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Indonesian Cardiovascular Research Center
Jakarta, DKI Jakarta, 11420
About this study
Official title: 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.
Read the 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.
- Conditions
- STEMI, Microvascular Coronary Artery Disease
- Being tested
- Long pentraxin 3
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long pentraxin 3Other
Primary PCI
| Study group | Role | What they receive |
|---|---|---|
| Genotypic variants | AA, AG and GG genotype Receives: Other: Long pentraxin 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of microvascular obstruction
Percentage
Measured: Immediate after pci
Secondary outcomes (1)
Incidence of mortality
Percentage
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Jan 2018
- Primary completion2 Aug 2018
- Study completion3 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 217 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Indonesian Cardiovascular Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surya Dharma, Indonesian Cardiovascular Research Center
- Investigators
- Surya Dharma, MD, PhD, Principal investigator, Indonesian Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907722
- Sponsor's protocol ID
- IndonesianCRC2
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 3q25 rs2305619 Polymorphism is Associated With Coronary Microvascular Obstruction Following Primary Angioplasty for Acute ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03907722
- Acronym / sponsor ID
- IndonesianCRC2
- Conditions
- STEMI, Microvascular Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Indonesian Cardiovascular Research CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 3 Sep 2018 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genotypic variants | – | Other: Long pentraxin 3AA, AG and GG genotype |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with STEMI symptom onset <12h admitted to the ED and planned for primary PCI
Key inclusion criteria (1 listed)
- Patients with acute STEMI with symptom onset <12 h and treated by primary PCI
Key exclusion criteria (1 listed)
- STEMI patients who received fibrinolytic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long pentraxin 3Primary PCI | Other | Genotypic variants |
Primary outcome
Incidence of microvascular obstruction
Time frame: Immediate after pci
Percentage
1 secondary outcome
Incidence of mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surya Dharma, MD, PhD principal investigator
Indonesian Cardiovascular Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI and Microvascular Coronary Artery Disease, run by Indonesian Cardiovascular Research Center at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of microvascular obstruction (time frame: Immediate after pci). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.