Acute Coronary Syndrome, Anxiety, Heart Diseases, Myocardial Infarction, ST Elevation Myocardial Infarction
Conditions
Keywords
Cardiology, Acute Coronary Syndrome, Heart Rate, Alprazolam, Anxiolytic
Brief summary
Cardiovascular disease has always been one of the most concerning ailments of all times considering mortality. On one end due to the emergence of pharmaceutical technology, there is a reduction in mortality, on the other hand owing to a sedentary lifestyle the incidence of this disease is increasing. Hence leading to up slopping trend in cardiovascular prevalence. Acute coronary syndrome is one of the most deadly and acute presentations of cardiology requiring immediate intervention to dampen the frequency of complications. One of the fundamental goals in the treatment of ACS is to lower the heart rate so that load on myocardial tissue can be reduced. In order to do so, we already have multiple options like beta-blockers, calcium channel blockers, and new generation ivabradine (not affecting blood pressure unlike others).
Detailed description
World has studied the increased prevalence of anxiety as a concomitant factor in ACS patients causing detrimental effects on cardiovascular outcomes being anxiety as one of the first responses to chest pain and hospital admission causing tachycardia. This study is designed to achieve the goals of lowering the heart using the anxiolytic property of alprazolam. This randomized, parallel group, close label, placebo-controlled, event driven, interventional clinical superiority study will be conducted in Cardiology department of Shaikh Zayed Hospital with a sample size of 48 allocating using lottery method in both experimental and control group. Heart Rate at baseline and after 6 hours will be monitored in both groups to establish the fall of heart rate in both patients. Data will be collected by using pre-designed performa and will be entered and analyzed via SAS 9.4. Statistical analysis will be done using T-test and p value \<0.05 will be considered significant. Significance of the study is to lower the required dosage of beta-blockers in order to achieve optimum beta-blockade using an anxiolytic while not affecting the blood pressure.
Interventions
DRUGAlprazolam
Alprazolam 0.5 mg will be given when the patient with acute coronary syndrome would present to the emergency
OTHERPlacebo
Empty capsule
Sponsors
Sohaib Ashraf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Masking will be done for all participants
Intervention model description
This randomized, close label, placebo-controlled study with superiority framework as add-on therapy in ACS patients
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Systolic BP\>100mm Hg Age between 18-80 years Sinus Rhythm
Exclusion criteria
* Cardiogenic Shock / Hypotension * Known Asthma/COPD * Bradycardia (HR \< 60) * Already on Beta blockers/ Anxiolytics * Sick sinus syndrome * Second or third-degree heart block (in the absence of pacemaker) * Decompensated heart failure * With documented hypersensitivity to the drug or components * Valvular Heart Diseases * Congenital Heart Diseases * Status post CABG * Any co-morbidities except Diabetes Mellitus and Hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | upto 72 hours | Heart Rate reduction |
| Duration of Hospital stay | upto 14 days | Number of days |
| Mortality | upto 14 days | death of patients |
| recurrent symptomatic ischemia | 72 hours | episodes of angina |
| erythrocyte sedimentation rate (ESR) | upto 72 hours | Acute phase reactants |
| C-reactive protein (CRP) | upto 72 hours | Acute phase reactants |
Countries
Pakistan
Contacts
Primary ContactSohaib Ashraf, MBBS
Backup ContactAhmad Imran, MBBS
Outcome results
None listed