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| Name | Class |
|---|---|
| Emergency NGO Onlus | OTHER |
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The intensive arterial pressure control in acute coronary syndrome (ACS) during the first 24 hours can improve the prognosis in the short and long term.
the study compare two treatment strategies (standard and intensive treatment) to assess their efficacy and safety in the treatment of acute coronary syndrome.
Acute coronary syndrome is often associated with arterial pressure elevation which are deleterious for the heart and needs urgent intervention to lower the blood pressure to the required values, however there is no clear recommendations concerning the treatment intensity in this situation.
The investigators know that high arterial pressure increases the oxygen myocardial consumption and it is deleterious in acute coronary syndrome, so , it is logical to reduce intensively this pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intensive controle group | Experimental | The end point in this group was to maintain the systolic blood pressure (SBP) between 110 and 120 mmHg using continuous intravenous Isosorbide Dinitrate perfusion, and Labetalol if needed. |
|
| standard control group | Active Comparator | The end point in these group was to maintain the systolic blood pressure under 140 mmHg using continuous intravenous Isosorbide Dinitrate perfusion, and Labetalol if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isosorbide Dinitrate | Drug | administration of continuous intravenous isosorbide dinitrate to obtain a SBP between 110 and 120 mmHg. After 2 hours from the start of treatment and if the blood pressure goal is not achieved, labetalol is used |
| Measure | Description | Time Frame |
|---|---|---|
| mortality | 1-year death rate | 12 months |
| major cardiovascular events (MACE) | 1-year MACE rate | 12months |
| combined mortality and MACE rate | combined mortality and MACE rate at one year. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| troponin change | troponin change between baseline and 24 hour after | 24 hours after baseline measurement |
| Adverse events | Severe hypotension |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Semir Nouira, MD | University of Monastir | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| university of Monastir | Monastir | 5000 | Tunisia |
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| Label | URL |
|---|---|
| official department website | View source |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D007548 | Isosorbide Dinitrate |
| ID | Term |
|---|---|
| D007547 | Isosorbide |
| D013012 | Sorbitol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 |
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The assessments of outcome is conducted by aninvestigator who did not participate in the randomization, protocol treatment or in-hospital clinical treatment of the patient.
|
| 24 hours after start of protocol intervention |
| Organic Chemicals |
| D002241 | Carbohydrates |