Adenosine Dual Source Computed Tomography (CT) Versus Adenosine Single Photon Emission Computed Tomography (SPECT)

November 11, 2013 updated by: Daniel S. Berman, Cedars-Sinai Medical Center

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Coronary Artery Disease

Description

Pilot 1:

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
  • Change in clinical status as determined by the investigator
  • Inability to be on same medication regime 24 hrs prior to Adeno-SPECT and Adeno DSCT
  • Patients with chronic renal failure (C.C.T. < 60 ml/m2/sec)
  • Patients with allergy to contrast iodinated media
  • Congestive heart failure
  • History of thromboembolic disorders
  • Multiple myeloma
  • Hyperthyroidism
  • Pheochromocytoma
  • Atrial fibrillation
  • Inability to perform breath hold for 12 seconds

Pilot 2:

All inclusions/exclusions are the same as Pilot 1, WITH THE ADDITION OF:

Inclusion Criteria:

  • Have had prior (within 30 days) positive Adeno-SPECT scan

Exclusion Criteria:

  • Patients with contraindications to coronary angiography

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Principal Investigator: Daniel S Berman, MD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria

May 1, 2009

First Posted (Estimate)

May 4, 2009

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 11, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB # 10928/11143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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