STEMINCT03894176
Association of Plasma PTX3 Concentration and Outcomes of STEMI
An observational study of STEMI and Coronary; Ischemic, run by Indonesian Cardiovascular Research Center at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- STEMI, Coronary; Ischemic
- What is being tested?
- Plasma PTX3 concentration
- How many people
- 335 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2018to 2 Sep 2018
- 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: All patients with STEMI with symptom onset <12 h who admiited to the emergency department and planned for primary PCI.
Who may be able to join
- Patients with acute STEMI with symptom onset <12 h undergoing primary PCI
Who cannot join
- Acute 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: 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.
Read the 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.
- Conditions
- STEMI, Coronary; Ischemic
- Being tested
- Plasma PTX3 concentration
- Medical subject headings
- ST Elevation Myocardial Infarction, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma PTX3 concentrationOther
Also called PTX3
Long pentraxin 3, thrombus burden, final TIMI flow, ST segment resolution, STEMI, primary PCI
| Study group | Role | What they receive |
|---|---|---|
| PTX3 concentration | First quartile, second quartile, third quartile and fourth quartile of PTX3 in ng/mL Receives: Other: Plasma PTX3 concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of thrombus grade 4&5 and final TIMI flow <3
PTX3 concentration was compared based on the outcome
Measured: Intraprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Jan 2018
- Primary completion2 Aug 2018
- Study completion2 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 335 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894176
- Sponsor's protocol ID
- IndonesianCRC
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Plasma Pentraxin 3 Concentration With Angiographic and Clinical Outcomes in STEMI Treated by Primary Angioplasty
- ClinicalTrials.gov ID
- NCT03894176
- Acronym / sponsor ID
- IndonesianCRC
- Conditions
- STEMI, Coronary; Ischemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 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
- 2 Sep 2018 (actual)
- First posted
- 28 Mar 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTX3 concentration | – | Other: Plasma PTX3 concentrationFirst quartile, second quartile, third quartile and fourth quartile of PTX3 in ng/mL |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with STEMI with symptom onset <12 h who admiited to the emergency department and planned for primary PCI.
Key inclusion criteria (1 listed)
- Patients with acute STEMI with symptom onset <12 h undergoing primary PCI
Key exclusion criteria (1 listed)
- Acute 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 |
|---|---|---|
| Plasma PTX3 concentrationAlso: PTX3Long pentraxin 3, thrombus burden, final TIMI flow, ST segment resolution, STEMI, primary PCI | Other | PTX3 concentration |
Primary outcome
The proportion of thrombus grade 4&5 and final TIMI flow <3
Time frame: Intraprocedure
PTX3 concentration was compared based on the outcome
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 28 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary; Ischemic, 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 28 Mar 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?
The proportion of thrombus grade 4&5 and final TIMI flow <3 (time frame: Intraprocedure). 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 28 Mar 2019.