Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI
PROMISE
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.
2 other identifiers
interventional
201
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2008
Typical duration for phase_3
1 active site
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
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 28, 2008
CompletedFirst Posted
Study publicly available on registry
October 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFebruary 18, 2013
February 1, 2013
3.6 years
October 28, 2008
February 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infarct size measured by MRI
between 5 and 10 days after acute myocardial infarction
Interventions
Single dose of adenosine. Solution for infusion of 0.45 mg/mL. Enteral use.
Eligibility Criteria
You may qualify if:
- patients older than 18 years.
- patients with acute coronary syndrome with ST segment elevation within six hours of the onset of symptoms.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David Garcia-Doradolead
- Hospital General Universitario Gregorio Marañoncollaborator
- Hospital Clínico Universitario de Valladolidcollaborator
- Hospital Universitario Virgen Macarenacollaborator
- Instituto de Ciencias del Corazoncollaborator
Study Sites (1)
ValldHebron Hospital
Barcelona, Barcelona, 08035, Spain
Related Publications (1)
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.
PMID: 25449504DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David García-Dorado, MD, PhD
Valle Hebron Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 28, 2008
First Posted
October 29, 2008
Study Start
October 1, 2008
Primary Completion
May 1, 2012
Study Completion
July 1, 2012
Last Updated
February 18, 2013
Record last verified: 2013-02