NCT00825435

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

3.9 years

First QC Date

January 19, 2009

Last Update Submit

September 16, 2019

Conditions

Acute Chest Pain

Keywords

Coronary CT angiogramCardiac imagingCost analysisacute chest painrisk stratificationcumulative costs over 90-days of providing treatment services

Outcome Measures

Primary Outcomes (1)

  • 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.

    90-days

Secondary Outcomes (2)

  • 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.

    90-days

  • 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.

    90-days

Study Arms (2)

1

EXPERIMENTAL

Coronary CT angiogram plus Standard of care (CTA+SOC)

Procedure: Coronary CT Angiogram

2

NO INTERVENTION

Standard of Care (SOC)

Interventions

Coronary CT AngiogramPROCEDURE

Coronary CT Angiogram

1

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75390, United States

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2009

First Posted

January 21, 2009

Study Start

October 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 17, 2019

Record last verified: 2019-09

Locations

US(1)