Acute Coronary Syndrome Clinical Trial
Official title:
Effects of Zolpidem CR in Sleep and Clinical Outcomes of Patients in Cardiac Intensive Care Unit
A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU
patients who had been diagnosed with acute coronary syndrome, using a sleep promoting drug
(zolpidem controlled release).
The study hypothesis is that sleeping better can improve the heart recovery in patients with
a diagnosis of acute coronary syndrome.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | January 2014 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients from 18 to 75 years of age - Diagnosis of acute coronary syndrome - Capable of swallowing pills - Capable of filling in the questionaires Exclusion Criteria: - Class IV heart failure according to the New York heart association functional class, - Patients in a coma - Patients receiving mechanical ventilation - Patients who regularly use benzodiazepines or other medications for inducing sleep |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital São Paulo | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Associação Fundo de Incentivo à Pesquisa | Conselho Nacional de Desenvolvimento Científico e Tecnológico |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sleep quality analogue visual scale | After receiving the drug or placebo at night, the next morning the patients fill in the sleep quality visual analogue scale | 3 consecutive mornings | No |
Other | The Pittsburgh Sleep Quality Index | Before the patient receives the drug/placebo, he fills in the Pittsburgh Sleep Quality Index | 1 day, before the intervention | No |
Other | Epworth Sleepiness Scale | Before receiving the drug or placebo at night, patients fill in the Epworth Sleepiness Scale | 1 day, before the intervention | No |
Other | Insomnia Severity Index | Before receiving the drug or placebo at night, patients fill in the Insomnia Severity Index | 1 day, before the intervention | No |
Primary | Sleep efficiency | A full-night polysomnography is conducted in the first night on the ICU | 1 day - the first night | No |
Secondary | Troponin T | The serum troponin T is measured previously of the intervention and daily for 3 consecutive days | Within the first 3 days after an acute coronary syndrome diagnosis | No |
Secondary | Creatine-kinase MB | The serum creatine-kinase MB is measured previously of the intervention and daily for 3 consecutive days | Within the first 3 days after an acute coronary syndrome diagnosis | No |
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