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| ID | Type | Description | Link |
|---|---|---|---|
| CardioHE, AFIP | Other Identifier | AFIP |
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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
The environment of an Intensive Care Unit (ICU) is notoriously inhospitable to patients who experience a period of sleep deprivation (SD). Recent research has shown that SD, even in the short-term, may be related to echo and electrocardiographic changes that may potentially be predictors of cardiac arrhythmias.
The objective is to evaluate the effects of early treatment with zolpidem controlled release (CR®) compared to a placebo on clinical and polysomnographic parameters for patients in a cardiac ICU who had recently been diagnosed with acute coronary syndrome.
A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU patients who had been diagnosed with acute coronary syndrome. The patients in group A will receive placebo and patients in group B will receive zolpidem CR® 12.5 mg from the first night of hospitalization until their discharge. Patients will undergo overnight full polysomnography on the first night in the ICU and will complete a sleep diary with a visual analogue scale to evaluate sleep quality in the morning after the first 3 nights of hospitalization. The results of the routine ICU laboratory tests including the serum levels of cardiac enzymes [troponin T and creatine kinase MB (CK-MB)] will be collected preceding the first dose of the drug/placebo, and then daily thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zolpidem CR 12.5mg | Experimental | Patients receive zolpidem CR 12.5mg at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital |
|
| Placebo | Placebo Comparator | Patients receive placebo at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zolpidem CR 12.5mg | Drug | Patients will be given zolpidem CR 12.5mg each night for, at least, 3 consecutive nights, including the first night on the Cardiac ICU, when the undergo a full-night polysomnography |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep efficiency | A full-night polysomnography is conducted in the first night on the ICU | 1 day - the first night |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Creatine-kinase MB |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The Pittsburgh Sleep Quality Index |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick R Burke, MD | Contact | 55-11-964288591 | doctorburke@hotmail.com | |
| Dalva R Poyares, MD PhD | Contact | 55-11-21490155 | poyares@unifesp.br |
| Name | Affiliation | Role |
|---|---|---|
| Patrick R Burke, MD | Associação Fundo de Incentivo à Pesquisa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital São Paulo | Recruiting | São Paulo | São Paulo | 04023062 | Brazil |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D012892 | Sleep Deprivation |
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D020920 | Dyssomnias |
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| Placebo | Drug | Patients will receive placebo pills at night, according to their usual sleep time, from the first night on the Cardiac ICU, until their hospital discharge |
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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 |
Before the patient receives the drug/placebo, he fills in the Pittsburgh Sleep Quality Index
| 1 day, before the intervention |
| Epworth Sleepiness Scale | Before receiving the drug or placebo at night, patients fill in the Epworth Sleepiness Scale | 1 day, before the intervention |
| Insomnia Severity Index | Before receiving the drug or placebo at night, patients fill in the Insomnia Severity Index | 1 day, before the intervention |
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |