Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005701
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Acute Cardiac Ischemia in Women in the ACITIPI Trial
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To conduct a series of five inter-related studies on acute cardiac ischemia ACI in women
Detailed Description:
BACKGROUND
Acute cardiac ischemia ACI including acute myocardial infarction AMI and unstable angina pectoris is the leading cause of death in women in the US Despite growing interest in ischemic coronary cardiac disease in women little research has focused on women in the most common site of ACI initial evaluation and care the emergency department ED Improving medical care quality and outcomes for ACI in women will require an understanding of genders influence on initial ED presentation diagnosis triage treatment and outcomesThe detail of prospectively-collected data and number of patients available for this project with the resulting large statistical power while savings the cost of the 18 million ACI-TIPI Trial data collection effort and the experience of the CCHSR in over a decade of related studies of factors influencing the triage treatment and outcome of ED patients with ACI provide this project with substantial promise of new and useful results
DESIGN NARRATIVE
The five studies included STUDY I Were womens emergency department ED presentations of ACI different from mens STUDY II Were there differences between women and men in the ED diagnosis and triage of patients with chest pain and other symptoms suggestive of ACI STUDY III Were there differences between women and men in the use of non-invasive and invasive treatments among patients presenting to the ED with ACI STUDY IV Were there significant differences between women and men in medical outcomes during the acute event and within 30 days following ED presentation with ACI STUDY V Had differences between women and men in their ED presentation diagnosis andor triage for chest pain or other symptoms compatible with ACI changed over the past 10-15 years In studying the impact of gender these studies also included analyses for primary and interaction effects related to patient sociodemographic features ED presenting clinical features physician type and training hospital type and ED setting health insurance type and include adjustments for patients probabilities of having ACI as well as their likelihood of acute cardiac mortality
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Acute cardiac ischemia ACI including acute myocardial infarction AMI and unstable angina pectoris is the leading cause of death in women in the US Despite growing interest in ischemic coronary cardiac disease in women little research has focused on women in the most common site of ACI initial evaluation and care the emergency department ED Improving medical care quality and outcomes for ACI in women will require an understanding of genders influence on initial ED presentation diagnosis triage treatment and outcomesThe detail of prospectively-collected data and number of patients available for this project with the resulting large statistical power while savings the cost of the 18 million ACI-TIPI Trial data collection effort and the experience of the CCHSR in over a decade of related studies of factors influencing the triage treatment and outcome of ED patients with ACI provide this project with substantial promise of new and useful results
DESIGN NARRATIVE
The five studies included STUDY I Were womens emergency department ED presentations of ACI different from mens STUDY II Were there differences between women and men in the ED diagnosis and triage of patients with chest pain and other symptoms suggestive of ACI STUDY III Were there differences between women and men in the use of non-invasive and invasive treatments among patients presenting to the ED with ACI STUDY IV Were there significant differences between women and men in medical outcomes during the acute event and within 30 days following ED presentation with ACI STUDY V Had differences between women and men in their ED presentation diagnosis andor triage for chest pain or other symptoms compatible with ACI changed over the past 10-15 years In studying the impact of gender these studies also included analyses for primary and interaction effects related to patient sociodemographic features ED presenting clinical features physician type and training hospital type and ED setting health insurance type and include adjustments for patients probabilities of having ACI as well as their likelihood of acute cardiac mortality
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL053900 | NIH | None | httpsreporternihgovquickSearchR01HL053900 |