Status:
TERMINATED
The Melatonin Adjunct in the Acute myocaRdial Infarction Treated With Angioplasty
Lead Sponsor:
Alberto Domínguez Rodríguez
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Background: Experimental studies have documented the beneficial effects of the endogenously produced antioxidant, melatonin, in reducing tissue damage and limiting cardiac pathophysiology in models of...
Detailed Description
See article for more detailed description: Contemporary Clinical Trials 28 (2007) 532-539
Eligibility Criteria
Inclusion
- Aged between 18 and 75 years.
- Having experienced continuous ischemic (cardiac) symptoms for at least 20 minutes.
- Having onset of symptoms of qualifying acute myocardial infarction within the past 6 hours and be expected to undergo primary angioplasty.
- Having an electrocardiogram indicative of an acute ST segment -elevation myocardial infarction showing:
- \> 2 mm ST segment elevation in 2 anterior or lateral leads; or \> 2 mm ST segment elevation in 2 inferior leads coupled with ST depression in 2 contiguous anterior leads for a total ST deviation of \> 8 mm; or new left bundle branch block with at least 1 mm concordant ST elevation.
- Being willing to provide informed consent (informed consent may be provided by a legally authorized representative if the patient is not able to provide it according to local ethical standards).
- Being willing and able to be followed for at least 3 months for evaluation.
Exclusion
- A patient will be ineligible for study entry if he/she meets any of the following criteria:
- prehospital thrombolysis,
- Killip class IV on admission,
- known history of prior myocardial infarction,
- known history of renal failure,
- history of severe allergic reaction,
- history of autoimmune diseases,
- pregnancy,
- severe concurrent illness with reduced short-term prognosis,
- inability to give informed consent and
- participation in another study within the past 30 days.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT00640094
Start Date
May 1 2013
End Date
November 1 2016
Last Update
July 22 2020
Active Locations (3)
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1
Hospital General Universitario Santa Lucia
Cartagena, Murcia, Spain, 30202
2
University Hospital of Canarias
San Cristóbal de La Laguna, Tenerife, Spain, E-38320
3
Hospital Universitario Marqués de Valdecilla
Santander, Spain