Myocardial Protection With Adenosine During Primary Percu... | NCT00781404

Studies
Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI

NCT00781404

Sponsor

David Garcia-Dorado

Status

Completed

Last Update Posted

Feb 18, 2013Estimated

Enrollment

201Actual

Phase

Phase 3

Conditions

Acute Myocardial Infarction

Interventions

Adenosine

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-006671-36	EudraCT Number

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

May 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Oct 28, 2008

First Submission Date that Met QC Criteria

Oct 28, 2008

First Posted Date

Oct 29, 2008Estimated

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

Feb 15, 2013

Last Update Posted Date

Feb 18, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Garcia-Dorado, MD, Hospital Universitari Vall d'Hebron Research InstituteSponsor-Investigator

Lead Sponsor

David Garcia-DoradoOTHER

Collaborators

Name	Class
Hospital General Universitario Gregorio Marañon	OTHER
Hospital Clínico Universitario de Valladolid	OTHER
Hospital Universitario Virgen Macarena	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

OBJECTIVE: to evaluate the safety and efficacy of a brief intracoronary infusion of ADO applied at the time of reperfusion to limit infarct size and LV remodelling in patients with ACSST submitted to primary ACTP.

DESIGN: Multicentric, prospective, randomised, parallel, placebo-controlled double-blind study.

PATIENTS: 200 patients older than 18 with ACSST and without prior myocardial infarction receiving primary PTCA within 6 hours after symptom onset.

Detailed Description

The main mechanism responsible for the sanitary impact of ischemic heart disease is cardiomyocyte cell death associated to acute coronary syndrome with ST segment elevation (ACSST). In most of these patients, performing PTCA or thrombolysis as soon as possible does not prevent the occurrence of myocardial necrosis involving a substantial portion of the area at risk. Intracoronary adenosine (ADO) at the time of reperfusion limits infarct size in animals, and preliminary clinical studies indicate that may be also protective in patients with ACSST receiving early reperfusion therapy. OBJECTIVE: to evaluate the safety and efficacy of a brief intracoronary infusion of ADO applied at the time of reperfusion to limit infarct size and LV remodelling in patients with ACSST submitted to primary ACTP. DESIGN: Multicentric, prospective, randomised, parallel, placebo-controlled double-blind study. PATIENTS: 200 patients older than 18 with ACSST and without prior myocardial infarction receiving primary PTCA within 6 hours after symptom onset. PROTOCOL: Intracoronary ADO (4mg) or placebo (saline) infusion distal to the culprit lesion immediately before stent deployment, NMR between 6 and 14 days and after 6 months. END-POINTS: Major: infarct size as measured by NMR, Secondary: changes in LV volumes and EF, and major cardiac events during the follow-up.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

201Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adenosine	Drug	Single dose of adenosine. Solution for infusion of 0.45 mg/mL. Enteral use.		Adenocor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infarct size measured by MRI		between 5 and 10 days after acute myocardial infarction

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients older than 18 years.
patients with acute coronary syndrome with ST segment elevation within six hours of the onset of symptoms.

Exclusion Criteria:

patients younger than 18 years and pregnant women.
patients with previous transmural infarction.
patients with clinical evidence of bronchospastic lung disease or prior bronchodilator therapy.
patients with pacemakers.
patients with TIMI flow higher than 1 and lower than 3.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David García-Dorado, MD, PhD	Valle Hebron Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ValldHebron Hospital		Barcelona	Barcelona	08035	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25449504	Derived	Garcia-Dorado D, Garcia-del-Blanco B, Otaegui I, Rodriguez-Palomares J, Pineda V, Gimeno F, Ruiz-Salmeron R, Elizaga J, Evangelista A, Fernandez-Aviles F, San-Roman A, Ferreira-Gonzalez I. Intracoronary injection of adenosine before reperfusion in patients with ST-segment elevation myocardial infarction: a randomized controlled clinical trial. Int J Cardiol. 2014 Dec 20;177(3):935-41. doi: 10.1016/j.ijcard.2014.09.203. Epub 2014 Oct 7.

ID	Term
D011684	Purine Nucleosides
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring