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

Study 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

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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Radiation: Dual Source Multidetector CT (DSCT) w/ Adenosine enhancement


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Dual Source Multidetector CT (DSCT) w/ Adenosine enhancement|Somatom Definition Dual Source CT Scanner Stress/Rest Image scan using weight based CT contrast dye|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnostic Imaging, Dual Source Multidetector Computed Tomography, Computed Tomography, CT, Single Photon Emission Computed Tomography, SPECT, Myocardial Perfusion, Atherosclerosis