Acute Cardiac Ischemia in Women in the ACI/TIPI Trial
Primary Purpose
Heart Diseases, Cardiovascular Diseases, Angina Pectoris
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Heart Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005701
First Posted
May 25, 2000
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005701
Brief Title
Acute Cardiac Ischemia in Women in the ACI/TIPI Trial
Study Type
Observational
2. Study Status
Record Verification Date
April 2000
Overall Recruitment Status
Completed
Study Start Date
July 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1997 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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 gender's influence on initial ED presentation, diagnosis, triage, treatment, and outcomes.The 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 $1.8 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 women's emergency department (ED) presentations of ACI different from men's? 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, and/or 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Cardiovascular Diseases, Angina Pectoris, Myocardial Ischemia
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
9180109
Citation
Coronado BE, Griffith JL, Beshansky JR, Selker HP. Hospital mortality in women and men with acute cardiac ischemia: a prospective multicenter study. J Am Coll Cardiol. 1997 Jun;29(7):1490-6. doi: 10.1016/s0735-1097(97)00077-6.
Results Reference
background
PubMed Identifier
9051556
Citation
Zucker DR, Griffith JL, Beshansky JR, Selker HP. Presentations of acute myocardial infarction in men and women. J Gen Intern Med. 1997 Feb;12(2):79-87. doi: 10.1046/j.1525-1497.1997.00011.x.
Results Reference
background
PubMed Identifier
8901726
Citation
Maynard C, Beshansky JR, Griffith JL, Selker HP. Influence of sex on the use of cardiac procedures in patients presenting to the emergency department. A prospective multicenter study. Circulation. 1996 Nov 1;94(9 Suppl):II93-8.
Results Reference
background
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Acute Cardiac Ischemia in Women in the ACI/TIPI Trial
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