Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI (PROMISE)
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ClinicalTrials.gov Identifier: NCT00781404 |
Recruitment Status
:
Completed
First Posted
: October 29, 2008
Last Update Posted
: February 18, 2013
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myocardial Infarction | Drug: Adenosine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 201 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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. |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | July 2012 |

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Drug: Adenosine
- Infarct size measured by MRI [ Time Frame: between 5 and 10 days after acute myocardial infarction ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781404
Spain | |
ValldHebron Hospital | |
Barcelona, Spain, 08035 |
Principal Investigator: | David García-Dorado, MD, PhD | Valle Hebron Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( EudraCT Number ) |
First Posted: | October 29, 2008 Key Record Dates |
Last Update Posted: | February 18, 2013 |
Last Verified: | February 2013 |
Keywords provided by David Garcia-Dorado, 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:
Infarction Myocardial Infarction Acute Coronary Syndrome Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Adenosine |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Arrhythmia Agents Vasodilator Agents Purinergic P1 Receptor Agonists Purinergic Agonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |