Coronary CT Angiography in Acute Chest Pain is a Cost Effective Risk Stratification Strategy

This study is currently recruiting participants.

Verified by University of Texas Southwestern Medical Center, January 2009

First Received: January 19, 2009 Last Updated: January 20, 2009 History of Changes

Sponsored by:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00825435

Purpose

This study will evaluate the impact of adding coronary computed tomographic angiography (CTA) on health care costs for diagnosing patients with acute chest pain.

Condition	Intervention	Phase
Acute Chest Pain	Procedure: Coronary CT Angiogram	Phase III

MedlinePlus related topics: Chest Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Single Group Assignment
Official Title:	Inclusion of Multi-Detector CT Angiography (MDCT) in Low to Intermediate Risk Chest Pain Patients Presenting to the Emergency Department; a Randomized Cost Analysis

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:

Determine if the cumulative costs over 90-days of providing treatment services are reduced when adding coronary CTA to the standard-of-care (CTA + SOC) in patients with acute chest pain compared to SOC alone. [ Time Frame: 90-days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine if the rate of hospitalizations, nuclear perfusion scans and interventional cardiac catheterizations will be reduced by adding the coronary CTA to the SOC (CTA + SOC) compared to the SOC alone. [ Time Frame: 90-days ] [ Designated as safety issue: No ]
Compare the rate of death, myocardial infarct (MI), acute coronary syndrome (ACS), and recidivism to the ED over 90-days when adding coronary CTA to the SOC (CTA + SOC) in ED patients with acute chest pain compared to the SOC alone group. [ Time Frame: 90-days ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	October 2008
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Coronary CT angiogram plus Standard of care (CTA+SOC)	Procedure: Coronary CT Angiogram Coronary CT Angiogram
2: No Intervention Standard of Care (SOC)

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Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

patients who complain of typical or atypical chest pain (that is compatible with ischemia during the past 12 hrs);
patients a prediction of low to intermediate risk of myocardial infarction and/or complications according to established criteria;
patients who have normal or non-diagnostic electrocardiograms;
patients who have negative cardiac biomarker including creatine kinase-MB, myoglobin, and/or cardiac troponin I at initial testing; patients who require admission to the hospital by the EP at the time of risk-stratification;
patients who require cardiology consultation in the ED 7. patients who are age 35 years or older;
patients who are able to hold their breath for ≥ 15 seconds (to obtain a quality static anatomical image, scanning requires at least fifteen seconds of breath holding;
patients who have heart rate of < 70 beats per minute before or after the administration of beta-blocker medication

Exclusion Criteria:

patients who have a contraindication to iodinated and/ or beta-blocking drugs; patients who have compromised renal function defined as creatinine ≥ 1.2 mg/dl;
patients who are pregnant, suspected pregnant or other vulnerable populations e.g., incarcerated patients;
patients who have documented CAD by prior invasive coronary angiography or coronary CT angiography and/or patients with coronary artery stents, prior angioplasty, or prior coronary artery bypass grafts (CABG);
patients who have had prior cardiac imaging (within the past year) with normal result including invasive coronary angiography, coronary CT angiography, or nuclear stress testing;
patients who are unstable; patients who have an electrocardiogram diagnostic of ischemia or myocardial infarction (significant Q waves, ST -segment deviations > 0.5 mm, or T wave inversions);
patients in atrial fibrillation or have markedly irregular rhythm 9. patients who have had contrast administration within the past 24hrs;
patients without an 18 gauge antecubital intravenous access; patients who have a medical home outside of the UTSWMC/Parkland Medical system.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825435

Contacts

Contact: Adam H Miller, MD

2149063179

adam.miller@utsouthwestern.edu

Locations

United States, Texas
Parkland Hospital	Recruiting
Dallas, Texas, United States, 75390
Contact: Valaria Hart, PhD 214-590-8966 Vhart@parknet.pmh.org

Sponsors and Collaborators

University of Texas Southwestern Medical Center

More Information

No publications provided

Responsible Party:	UT Southwestern Medical Center ( Adam H. Miller )
Study ID Numbers:	032007-067
Study First Received:	January 19, 2009
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00825435 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

Coronary CT angiogram
Cardiac imaging
Cost analysis

acute chest pain
risk stratification
cumulative costs over 90-days of providing treatment services

Study placed in the following topic categories:

Signs and Symptoms
Emergencies
Pain
Chest Pain

Additional relevant MeSH terms:

Signs and Symptoms
Pain
Chest Pain

ClinicalTrials.gov processed this record on May 07, 2009