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

Patients Admitted With the Diagnosis of ST-elevation Acute Coronary Syndrome Clinical Trial

— ARTERIA  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01757886
• Other study ID #: ARTERIA-2012
• Secondary ID: ARTERIA-2012
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2012
• Last updated: December 22, 2012
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2012
• Source: Fundación Canaria Rafael Clavijo para la Investigación Biomédica
• Contact: Alberto Dominguez-Rodriguez, MD, PhD
• Phone: +34 922 679040
• Email: adrvdg[@]hotmail.com
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical 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 ST-elevation acute coronary syndrome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Myocardial Infarction
• Patients Admitted With the Diagnosis of ST-elevation Acute Coronary Syndrome

Intervention

Other:
• Biomarkers to analyze both intracoronary thrombi as blood

Locations

Country	Name	City	State
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz de Tenerife
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz de Tenerife
Spain	Hospital Universitario de Canarias	La Laguna	Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		one year	No