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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00933400
Other study ID # ACRIN PA 4005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2009
Est. completion date April 2012

Study information

Verified date February 2024
Source American College of Radiology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This multi-center, randomized, controlled trial conducted in Emergency Departments (ED) compares computed tomography (CT) coronary angiography with the traditional approach (usual care) for low- to intermediate-risk chest pain patients. The primary objective is to estimate the rate of major cardiac events (heart attack or cardiac death) within 30 days in trial participants in Group B who were not found to have significant coronary artery disease by CT coronary angiography. Additional evaluations will comprise health care utilization assessments, including length of hospital stay and re-admissions, cost analysis, and 1-year post-triage/presentation major cardiac event rates.


Description:

In this study, participants with potential ACS will be randomized to traditional "rule out" care (Group A) or to traditional care plus CT coronary angiography (Group B) in a ratio of 1:2 traditional versus traditional plus CT coronary angiography. In Group A, all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will be admitted to hospital, admitted to cardiac diagnostic unit, or discharged to home. Diagnostic testing and treatment will be decided by the team caring for the participant. Follow up will comprise telephone interviews after 30 days and 1 year from triage/presentation. In Group B, participants will receive initial cardiac troponin and creatinine blood tests. Upon return of normal laboratory values, the participants will receive a CT coronary angiography an estimated 90 minutes after the initial values assessment or as soon as the CT scanner is available. Participants with negative test results will be discharged; follow up will comprise telephone interviews after 30 days and 1 year from triage/presentation. Participants with positive test results will be admitted to the hospital for further management dictated by the admitting team.


Recruitment information / eligibility

Status Completed
Enrollment 1392
Est. completion date April 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria: - Participant is 30 years of age or older - Participant presents with complaints consistent with potential ACS (e.g., chest pain, shortness of breath, other) - Participant requires admission or objective testing to exclude ACS - Participant with initial ECG result without acute ischemia - Participant with an initial Thrombolysis in Myocardial Infarction (TIMI) Risk Score of 0 to 2 - Participant is willing to provide a written informed consent Exclusion Criteria: - Patients who present with symptoms that are clearly not cardiac in origin (e.g., chest pain secondary to herpes zoster, obvious pneumonia, or recent trauma); - Patients with no initial ECG performed in the ED - Patients with ST-elevation myocardial infarction (STEMI) - Patients with existing co-morbidity that requires admission regardless of presence of ACS (e.g., uncontrolled diabetes) - Patients with known contraindications to CT coronary angiography: Iodinated contrast allergic-like reaction - Patients who are known to have had CT coronary angiography in the year prior to presentation - Patients who are known to have normal catheterization results (no or minimal, < 25%, stenosis) in the year prior to presentation - Patients who are pregnant - Patients with known renal insufficiency (e.g., creatinine clearance < 60 mL/min/1.73 m2) - Patients with no telephone or cell phone numbers (preventing follow up) - Patients unwilling to provide a written informed consent

Study Design


Intervention

Diagnostic Test:
CT Coronary Angiography (CTCA)
CT coronary angiography will be performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test will be considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results will be communicated to the responsible ED and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.
Procedure:
Traditional Strategy
Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.

Locations

Country Name City State
United States Penn State Hershey - Milton S. Hershey Medical Center Hershey Pennsylvania
United States Penn-Presbyterian Medical Center Philadelphia Pennsylvania
United States University of Pennsylvania Health System Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Wake Forest University Baptist Medical Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
American College of Radiology Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days To estimate the rate of major cardiac events (AMI or cardiac death) within 30 days of discharge from Emergency Department (ED) - patient follow-up included telephone interviews 30 days and 1 year after triage/presentation.
Participants in Group B who were found not to have stenosis of the main or first order coronary branches greater than or equal to 50% by CT coronary angiography were considered negative and considered discharged if they were not designated to receive an inpatient bed or formal observation status.
All myocardial infarctions were reviewed by an Adjudication Committee to confirm diagnosis.
up to 30 days of discharge from the ED
Secondary Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review. The algorithm used for diagnosis of Significant coronary artery disease is provided in the Appendix of the protocol. baseline
Secondary Mean Length of Hospital Stay After Initial Visit Compare the length of hospital stay in hours between the groups 1-7 days
Secondary Health Care Utilization During the Index Hospitalization. Downstream diagnostic test during the index visit including Hospital admission or observation. 1-7 Days
Secondary Cardiac Health Care Utilization 1 Year Post Triage/Presentation. Through 1-yr study follow up
Secondary Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation MACE at 1 year was determined by Patient telephone contact Medical record review Records at the presenting and neighboring hospitals were reviewed for repeat visits When these methods failed to provide survival information, we searched the Social Security Death Master File Through 1-yr study follow up
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