Skip to main content
Clinical Trials/NCT00892307
NCT00892307
Completed
Not Applicable

Coronary Anatomy and Physiology Using Multidetector Dual Source Computed Tomography With Adenosine Enhancement: Comparative Study With SPECT Imaging: Pilot Studies I/II

Cedars-Sinai Medical Center1 site in 1 country34 target enrollmentFebruary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Cedars-Sinai Medical Center
Enrollment
34
Locations
1
Primary Endpoint
To show that adenosine enhanced DSCT will enhance regular Multidetector Spiral Computed Tomography (MSCT) "diagnostic power" to detect significant (e.g., > 50%) coronary stenosis
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Researchers hope that this new non-invasive multi-detector scanner (DSCT) will provide diagnostic information comparable to the combination of traditional SPECT (for function and blood flow) and CT imaging (for a precise anatomical view).

Detailed Description

The DSCT scanner is able to assess cardiac blood flow (myocardial perfusion) at the same time as coronary anatomy. The results derived from these scans will be compared to standard SPECT imaging. To further evaluate obstruction in the coronary arteries, physicians may refer for an invasive Coronary Angiogram, the current gold standard for diagnosis of Coronary Artery Disease (CAD). By validating the DSCT scanner as a system with which to assess the extent of obstruction in the coronary arteries, physicians may be able to lessen the occurrence of an invasive exam. Procedures: Each pilot anticipates enrolling 20 subjects. Pilot 1: Clinical Follow-up Rest/Stress Adeno-SPECT and Research Stress /Rest Adeno-DSCT obtained in the same patient during the same period of stress testing * Radiation: Thallium injection for rest SPECT * Drug: Single dose Adenosine Infusion for DSCT and SPECT * Radiation: Sestamibi injection for stress SPECT * Drug: CT contrast * Radiation: Stress DSCT /Rest DSCT Pilot 2: Research Stress/ Rest Adeno-DSCT obtained within 30 days of initial positive SPECT finding * Drug: Adenosine Infusion for DSCT * Drug: CT contrast * Radiation: Stress DSCT /Rest DSCT Both pilot studies will relate results to subject history, ECG and cardiac angiogram, if available

Registry
clinicaltrials.gov
Start Date
February 2007
End Date
May 2011
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel S. Berman

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

Inclusion Criteria

  • Provide written consent and are willing to comply with protocol requirements
  • Are at least 18 years of age
  • Are referred for clinically-ordered SPECT
  • Have known CAD

Exclusion Criteria

  • Patients being referred to invasive coronary angiography will not be included in this pilot
  • Caffeine intake within the 24 hours prior to adenosine stress testing
  • Pregnancy (known or suspected)
  • Intolerance or contraindication to adenosine (severe Asthma...)
  • Intake of methylxanthine containing medications such as theophylline that have not been withdrawn and would interfere with the effectiveness of adenosine.
  • Unstable coronary syndromes
  • Uncontrolled congestive cardiac failure or cardiogenic shock
  • Uncontrolled hypertension with resting BP \> 200/110
  • More than 30 days between the Adeno-SPECT and the Adeno-DSCT
  • Revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery) between the Adeno-SPECT and the Adeno-DSCT

Outcomes

Primary Outcomes

To show that adenosine enhanced DSCT will enhance regular Multidetector Spiral Computed Tomography (MSCT) "diagnostic power" to detect significant (e.g., > 50%) coronary stenosis

Time Frame: One day

Secondary Outcomes

  • To assess coronary anatomical results obtained by CT Angiography (CTA) at high heart rates in terms of the rate of assessable coronary segments.(One day)

Study Sites (1)

Loading locations...

Similar Trials