inflAmmatory maRkers in Blood and Thrombus Aspirated From... | NCT01757886

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

NCT01757886

Sponsor

Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Status

Unknown status

Last Update Posted

Dec 31, 2012Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

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

Interventions

Biomarkers to analyze both intracoronary thrombi as blood

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
ARTERIA-2012	Other Identifier	Fundacion Canaria Rafael Clavijo

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2013Estimated

First Submitted Date

Dec 22, 2012

First Submission Date that Met QC Criteria

Dec 22, 2012

First Posted Date

Dec 31, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2012

Last Update Posted Date

Dec 31, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Enrique Quintero, Alberto Dominguez Rodriguez, Fundación Canaria Rafael Clavijo para la Investigación BiomédicaPrincipal Investigator

Lead Sponsor

Fundación Canaria Rafael Clavijo para la Investigación BiomédicaOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Biomarkers to analyze both intracoronary thrombi as blood	Other		ST-elevation acute coronary syndrome

Outcomes Module

Primary Outcomes

Measure	Description	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		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alberto Dominguez-Rodriguez, MD, PhD	Contact	+34 922 679040		adrvdg@hotmail.com

Overall Officials

Name	Affiliation	Role
Alberto Dominguez-Rodriguez, MD, PhD	Hospital Universitario de Canarias	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario de Canarias	Recruiting	San Cristóbal de La Laguna	Santa Cruz de Tenerife	E-38320	Spain

ID	Term
D009203	Myocardial Infarction
D007249	Inflammation
D013927	Thrombosis

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis
D016769	Embolism and Thrombosis

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D011677	Punctures
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques