NCT01757886

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 31, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 31, 2012

Status Verified

December 1, 2012

Enrollment Period

Same day

First QC Date

December 22, 2012

Last Update Submit

December 22, 2012

Conditions

Keywords

Myocardial infarction, Inflammation, Thrombus, Coronary angioplasty.

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

ST-elevation acute coronary syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, E-38320, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, E-38320, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionInflammationThrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Alberto Dominguez-Rodriguez, MD, PhD

    Hospital Universitario de Canarias

    STUDY CHAIR

Central Study Contacts

Alberto Dominguez-Rodriguez, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Alberto Dominguez Rodriguez

Study Record Dates

First Submitted

December 22, 2012

First Posted

December 31, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2013

Last Updated

December 31, 2012

Record last verified: 2012-12

Locations