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

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Adenosine
Sponsored by
David Garcia-Dorado
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring adenosine, angioplasty, acute myocardial infarction, acute coronary syndrome with ST segment elevation, infarct size, rescued myocardium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ValldHebron Hospital

Outcomes

Primary Outcome Measures

Infarct size measured by MRI

Secondary Outcome Measures

Full Information

First Posted
October 28, 2008
Last Updated
February 15, 2013
Sponsor
David Garcia-Dorado
Collaborators
Hospital General Universitario Gregorio Marañon, Hospital Clínico Universitario de Valladolid, Hospital Universitario Virgen Macarena, Instituto de Ciencias del Corazon
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1. Study Identification

Unique Protocol Identification Number
NCT00781404
Brief Title
Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI
Acronym
PROMISE
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Garcia-Dorado
Collaborators
Hospital General Universitario Gregorio Marañon, Hospital Clínico Universitario de Valladolid, Hospital Universitario Virgen Macarena, Instituto de Ciencias del Corazon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
adenosine, angioplasty, acute myocardial infarction, acute coronary syndrome with ST segment elevation, infarct size, rescued myocardium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adenosine
Other Intervention Name(s)
Adenocor
Intervention Description
Single dose of adenosine. Solution for infusion of 0.45 mg/mL. Enteral use.
Primary Outcome Measure Information:
Title
Infarct size measured by MRI
Time Frame
between 5 and 10 days after acute myocardial infarction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David García-Dorado, MD, PhD
Organizational Affiliation
Valle Hebron Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ValldHebron Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25449504
Citation
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.
Results Reference
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Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI

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