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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
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Drug: Adenosine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Infarct size measured by MRI [ Time Frame: between 5 and 10 days after acute myocardial infarction ] [ Designated as safety issue: No ]

Enrollment: 201
Study Start Date: October 2008
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Adenosine
    Single dose of adenosine. Solution for infusion of 0.45 mg/mL. Enteral use.
    Other Name: Adenocor
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781404

Locations
Spain
ValldHebron Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
David Garcia-Dorado
Hospital General Universitario Gregorio Marañon
Hospital Clinico Universitario de Valladolid
Hospital Universitario Virgen de la Macarena
Instituto de Ciencias del Corazon
Investigators
Principal Investigator: David García-Dorado, MD, PhD Valle Hebron Hospital
  More Information

No publications provided

Responsible Party: David Garcia-Dorado, MD, Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT00781404     History of Changes
Other Study ID Numbers: HUValldHebronRI, 2007-006671-36
Study First Received: October 28, 2008
Last Updated: February 15, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
adenosine
angioplasty
acute myocardial infarction
acute coronary syndrome with ST segment elevation
infarct size
rescued myocardium

Additional relevant MeSH terms:
Acute Coronary Syndrome
Infarction
Myocardial Infarction
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Adenosine
Analgesics
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014