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

This study is currently recruiting participants.
Verified December 2012 by Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Sponsor:
Information provided by (Responsible Party):
Enrique Quintero, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
ClinicalTrials.gov Identifier:
NCT01757886
First received: December 22, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Patients Admitted With the Diagnosis of ST-elevation Acute Coronary Syndrome
Other: Biomarkers to analyze both intracoronary thrombi as blood

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months

Resource links provided by NLM:


Further study details as provided by Fundación Canaria Rafael Clavijo para la Investigación Biomédica:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757886

Contacts
Contact: Alberto Dominguez-Rodriguez, MD, PhD +34 922 679040 adrvdg@hotmail.com

Locations
Spain
Hospital Universitario de Canarias Recruiting
La Laguna, Santa Cruz de Tenerife, Spain, E-38320
Contact: Alberto Dominguez-Rodriguez, MD, PhD    +34 922 679040    adrvdg@hotmail.com   
Principal Investigator: Alberto Dominguez-Rodriguez, MD, PhD         
Hospital Universitario de Canarias Recruiting
La Laguna, Santa Cruz de Tenerife, Spain, E-38320
Contact: Alberto Dominguez-Rodriguez, MD, PhD    +34 922679040    adrvdg@hotmail.com   
Hospital Universitario de Canarias Recruiting
La Laguna, Tenerife, Spain, 38320
Contact: Alberto Dominguez-Rodriguez, MD, PhD    +34 922 679040    adrvdg@hotmail.com   
Sponsors and Collaborators
Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Investigators
Study Chair: Alberto Dominguez-Rodriguez, MD, PhD Hospital Universitario de Canarias
  More Information

No publications provided

Responsible Party: Enrique Quintero, Alberto Dominguez Rodriguez, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
ClinicalTrials.gov Identifier: NCT01757886     History of Changes
Other Study ID Numbers: ARTERIA-2012, ARTERIA-2012
Study First Received: December 22, 2012
Last Updated: December 22, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by Fundación Canaria Rafael Clavijo para la Investigación Biomédica:
Myocardial infarction, Inflammation, Thrombus, Coronary angioplasty.

Additional relevant MeSH terms:
Myocardial Infarction
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014