Status:
COMPLETED
A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in STEMI
Lead Sponsor:
University of Alberta
Conditions:
STEMI
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The PANACEA trial is an investigator-initiated prospective, single-center, two-arm, non-blinded pilot randomized controlled trial of high-dose IV N-Acetylcysteine therapy used as an adjunct to pharmac...
Detailed Description
Patients presenting with ST-segment elevation myocardial infarction within 3 hours of symptom onset and satisfying all of the inclusion criteria after informed consent would be randomly allocated to e...
Eligibility Criteria
Inclusion
- Patients presenting with STEMI within 3 hours of symptom onset and satisfying all of the following criteria:
- Patient age ≥ 18 years
- Have received thrombolysis, with intend to pursue a pharmaco-invasive reperfusion strategy. Onset of chest pain to reperfusion time of \< 3hrs.
- STEMI involving anterior and/or inferior wall
- An absence of baseline Q-waves on the initial ECG: The presence of Q waves defined at baseline using the Selvester QRS screening criteria
- Have a high-risk STEMI ECG defined as:
- ≥2mm ST-segment elevation in 2 anterior or lateral leads; or
- ≥2 mm ST-segment elevation in 2 inferior leads coupled with ST-segment depression in 2 contiguous anterior leads for a total ST-segment deviation of ≥4 mm
Exclusion
- Previous myocardial infarction
- Known to have moderate to severe LV systolic dysfunction (LV EF\< 45%)
- Known allergy to thrombolytic therapy or NAC
- Presence of left bundle branch block
- Cardiogenic shock (defined as systolic blood pressure of \< 90mm Hg, for at least 30 minutes, not responsive to fluid resuscitation)
- Permanent pacemaker or cardioverter defibrillator implanted previously
- Patients with contra-indications to thrombolytic therapy
- Patients with loss of consciousness or confusion
- Patients with known chronic kidney disease (GFR \< 30ml/min/m2) or on dialysis
- Current pregnancy
- Planned therapy with primary PCI
Key Trial Info
Start Date :
September 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04023266
Start Date
September 20 2019
End Date
January 1 2022
Last Update
October 6 2022
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7