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Acute Cardiac Ischemia in Women in the ACI/TIPI Trial

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005701
First received: May 25, 2000
Last updated: February 17, 2016
Last verified: April 2000
  Purpose
To conduct a series of five inter-related studies on acute cardiac ischemia (ACI) in women.

Condition
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Myocardial Ischemia

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1994
Study Completion Date: June 1997
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.

  Eligibility

Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005701     History of Changes
Other Study ID Numbers: 4301  R01HL053900 
Study First Received: May 25, 2000
Last Updated: February 17, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Angina Pectoris
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on December 08, 2016