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OpenTrials
Completed

NCT Number: NCT00781404

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ValldHebron Hospital

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adenosine

Drug

Single dose of adenosine. Solution for infusion of 0.45 mg/mL. Enteral use.

Other names: Adenocor

Primary outcomes

  1. Infarct size measured by MRI

    Time frame: between 5 and 10 days after acute myocardial infarction

Sponsors and collaborators

Lead sponsor

David Garcia-Dorado

Other

Collaborators

  • Hospital Clínico Universitario de Valladolid
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario Virgen Macarena
  • Instituto de Ciencias del Corazon

Registry information

Official study 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.

Acronym: PROMISE

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 29, 2008
Registry last updated
Feb 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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