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Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI (PROMISE)

This study has been completed.
Sponsor:
Collaborators:
Hospital General Universitario Gregorio Marañon
Hospital Clinico Universitario de Valladolid
Hospital Universitario Virgen de la Macarena
Instituto de Ciencias del Corazon
Information provided by (Responsible Party):
David Garcia-Dorado, Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT00781404
First received: October 28, 2008
Last updated: February 15, 2013
Last verified: February 2013

October 28, 2008
February 15, 2013
October 2008
May 2012   (final data collection date for primary outcome measure)
Infarct size measured by MRI [ Time Frame: between 5 and 10 days after acute myocardial infarction ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00781404 on ClinicalTrials.gov Archive Site
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Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI
Myocardial Protection During reperfusión in Patients With Acute Coronary Syndrome With ST Segment Elevation Submitted to Primary Angioplasty: Effect of Intracoronary Adenosine on Infarct Size and Ventricular Remodeling.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acute Myocardial Infarction
Drug: Adenosine
Single dose of adenosine. Solution for infusion of 0.45 mg/mL. Enteral use.
Other Name: Adenocor
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
July 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00781404
HUValldHebronRI, 2007-006671-36
No
David Garcia-Dorado, Hospital Universitari Vall d'Hebron Research Institute
David Garcia-Dorado
  • Hospital General Universitario Gregorio Marañon
  • Hospital Clinico Universitario de Valladolid
  • Hospital Universitario Virgen de la Macarena
  • Instituto de Ciencias del Corazon
Principal Investigator: David García-Dorado, MD, PhD Valle Hebron Hospital
Hospital Universitari Vall d'Hebron Research Institute
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP