inflAmmatory maRkers in Blood and Thrombus Aspirated From Patients With acutE myocaRdial Infarction With St-segment elevAtion (ARTERIA)

December 22, 2012 updated by: Enrique Quintero, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

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

  • Spain
    • Santa Cruz de Tenerife
      • La Laguna, Santa Cruz de Tenerife, Spain, E-38320
        • Recruiting
        • Hospital Universitario de Canarias
        • Contact:
          • Alberto Dominguez-Rodriguez, MD, PhD
          • Phone Number: +34 922679040
          • Email: adrvdg@hotmail.com
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
        • Contact:
          • Alberto Dominguez-Rodriguez, MD, PhD
          • Phone Number: +34 922 679040
          • Email: adrvdg@hotmail.com

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Biomarkers to analyze both intracoronary thrombi as blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Investigators

  • Study Chair: Alberto Dominguez-Rodriguez, MD, PhD, Hospital Universitario de Canarias

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

November 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

December 22, 2012

First Submitted That Met QC Criteria

December 22, 2012

First Posted (Estimate)

December 31, 2012

Study Record Updates

Last Update Posted (Estimate)

December 31, 2012

Last Update Submitted That Met QC Criteria

December 22, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARTERIA-2012 (Other Identifier: Fundacion Canaria Rafael Clavijo)

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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