Patients Admitted With the Diagnosis of ST-elevation Acute Coronary SyndromeARTERIANCT01757886
inflAmmatory maRkers in Blood and Thrombus Aspirated From Patients With acutE myocaRdial Infarction With St-segment elevAtion
An observational study of Patients Admitted With the Diagnosis of ST-elevation Acute Coronary Syndrome, run by Fundación Canaria Rafael Clavijo para la Investigación Biomédica at 3 sites in Spain.
Trial summary
The prognostic value of inflammatory markers in acute coronary syndrome has been extensively demonstrated, however it is still unknown whether there is an association between circulating and local (thrombus) inflammatory molecules, and the subset of molecules that provide better prognostic information in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Admitted With the Diagnosis of ST-elevation Acute Coronary Syndrome
- What is being tested?
- Biomarkers to analyze both intracoronary thrombi as blood
- How many people
- 100 participants
- Where
- 3 sitesSpain
- Study dates
- Nov 2012to Nov 2013
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pilot, prospective cohort, which included all patients admitted with a diagnosis of ST-elevation myocardial infarction and undergoing thrombus aspiration during a procedure effective emerging percutaneous coronary revascularization.
Who may be able to join
- They include patients of both sexes, without limits of age, with a diagnosis of STEMI within 12 hours after the beginning of symptoms. ST-elevation myocardial infarction was defined in the presence of symptoms consistent, persistent elevation (> 20 min) ST segment ≥ 1 mm in at least two contiguous leads or in the presence of left bundle branch block presumably new onset and cardiac troponin I elevation
Who cannot join
- Injury significant common core of left coronary artery (stenosis greater than or equal to 50% of the vessel lumen).
- Pre-Fibrinolysis percutaneous coronary intervention.
- Previous coronary bypass surgery.
- Thyrotoxicosis.
- Having an inflammatory systemic or local inflammatory process.
- Malignant neoplasm.
- Any disease that seriously compromise the prognosis and / or systemic inflammatory response generated.
- No thrombotic material obtained in the thrombus or insufficient for performing biochemical determinations.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, E-38320
Alberto Dominguez-Rodriguez, MD, PhD, +34 922 679040, adrvdg@hotmail.com
Alberto Dominguez-Rodriguez, MD, PhD
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, E-38320
Alberto Dominguez-Rodriguez, MD, PhD, +34 922679040, adrvdg@hotmail.com
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Alberto Dominguez-Rodriguez, MD, PhD, +34 922 679040, adrvdg@hotmail.com
About this study
The prognostic value of inflammatory markers in acute coronary syndrome has been extensively demonstrated, however it is still unknown whether there is an association between circulating and local (thrombus) inflammatory molecules, and the subset of molecules that provide better prognostic information in patients with ST-elevation acute coronary syndrome.
- Being tested
- Biomarkers to analyze both intracoronary thrombi as blood
- Keywords
- Myocardial infarction, Inflammation, Thrombus, Coronary angioplasty.
- Medical subject headings
- Myocardial Infarction, Inflammation, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers to analyze both intracoronary thrombi as bloodOther
| Study group | Role | What they receive |
|---|---|---|
| ST-elevation acute coronary syndrome | ARTERY is a prospective, multicenter, which will include patients admitted with the diagnosis of ST-elevation acute coronary syndrome and thrombus aspiration is performed during primary angioplasty Receives: Other: Biomarkers to analyze both intracoronary thrombi as blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to find out whether there is an association between certain inflammatory markers in blood and intracoronary thrombus and whether these markers are associated with the composite of all-cause mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2012
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Admitted With the Diagnosis of ST-elevation Acute Coronary SyndromeStudies 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
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fundación Canaria Rafael Clavijo para la Investigación Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrique Quintero, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
- Investigators
- Alberto Dominguez-Rodriguez, MD, PhD, Study chair, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757886
- Sponsor's protocol ID
- ARTERIA-2012
- Other IDs
- ARTERIA-2012
- Acronym
- ARTERIA
- Status last verified
- Dec 2012
- First submitted
- 22 Dec 2012
- Last updated
- 31 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- inflAmmatory maRkers in Blood and Thrombus Aspirated From Patients With acutE myocaRdial Infarction With St-segment elevAtion
- ClinicalTrials.gov ID
- NCT01757886
- Acronym / sponsor ID
- ARTERIA / ARTERIA-2012
- Keywords
- Myocardial infarction, Inflammation, Thrombus, Coronary angioplasty.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundación Canaria Rafael Clavijo para la Investigación BiomédicaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2013 (estimated)
- First posted
- 31 Dec 2012 (estimated)
- 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 prognostic value of inflammatory markers in acute coronary syndrome has been extensively demonstrated, however it is still unknown whether there is an association between circulating and local (thrombus) inflammatory molecules, and the subset of molecules that provide better prognostic information in patients with ST-elevation acute coronary syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ST-elevation acute coronary syndrome | – | Other: Biomarkers to analyze both intracoronary thrombi as bloodARTERY is a prospective, multicenter, which will include patients admitted with the diagnosis of ST-elevation acute coronary syndrome and thrombus aspiration is performed during primary angioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pilot, prospective cohort, which included all patients admitted with a diagnosis of ST-elevation myocardial infarction and undergoing thrombus aspiration during a procedure effective emerging percutaneous coronary revascularization.
Key inclusion criteria (1 listed)
- They include patients of both sexes, without limits of age, with a diagnosis of STEMI within 12 hours after the beginning of symptoms. ST-elevation myocardial infarction was defined in the presence of symptoms consistent, persistent elevation (> 20 min) ST segment ≥ 1 mm in at least two contiguous leads or in the presence of left bundle branch block presumably new onset and cardiac troponin I elevation
Key exclusion criteria (8 listed)
- Injury significant common core of left coronary artery (stenosis greater than or equal to 50% of the vessel lumen).
- Pre-Fibrinolysis percutaneous coronary intervention.
- Previous coronary bypass surgery.
- Thyrotoxicosis.
- Having an inflammatory systemic or local inflammatory process.
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 |
|---|---|---|
| Biomarkers to analyze both intracoronary thrombi as blood | Other | ST-elevation acute coronary syndrome |
Primary outcome
The primary objective of the study is to find out whether there is an association between certain inflammatory markers in blood and intracoronary thrombus and whether these markers are associated with the composite of all-cause mortality
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2012.
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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.
Alberto Dominguez-Rodriguez, MD, PhD study chair
Hospital Universitario de Canarias
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Admitted With the Diagnosis of ST-elevation Acute Coronary Syndrome, run by Fundación Canaria Rafael Clavijo para la Investigación Biomédica at 3 sites in Spain.
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 8 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: status not confirmed, as of the sponsor's last update on 31 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Dominguez-Rodriguez, MD, PhD (+34 922 679040, adrvdg@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of the study is to find out whether there is an association between certain inflammatory markers in blood and intracoronary thrombus and whether these markers are associated with the composite of all-cause mortality (time frame: one year). 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 31 Dec 2012.