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Detecting Heart Disease Using First Pass Imaging With Gated SPECT Perfusion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01137409
First Posted: June 4, 2010
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Yale University
  Purpose
The aim of this study is to determine if stress first pass imaging in conjunction with a nuclear scan will improve the sensitivity for detecting heart disease. This study will also test the usefulness of a nuclear medicine camera, CDLCAM One Pass Angiography system.

Condition
Ischemic Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detecting Heart Disease Using First Pass Imaging With Gated SPECT Perfusion

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • To determine if stress first pass imaging in conjunction with gated SPECT, with or with out low level exercise,will improve the sensitivity for detecting ischemic heart disease [ Time Frame: First pass imaging done in conjunction with SPECT study ]
    First pass imaging will be done in conjunction with the clinically indicated SPECT study.


Secondary Outcome Measures:
  • To determine if first pass imaging provides a more reproducible approach for evaluation of both rest and stress global LV function over gated SPECT perfusion imaging compared with 3D echocardiography [ Time Frame: Immediately following administration of regadenoson. ]
    Echocardiography will be done immediately following the administration of regadenoson.


Enrollment: 40
Study Start Date: August 2010
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Suspected or Diagnosed with Coronary artery disease
All patients with suspected or previously diagnosed coronary artery disease

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with suspected or previously diagnosed coronary artery disease that are clinically referred for either a treadmill exercise stress/rest SPECT study or an adenosine vasodilatation stress/rest SPECT study will be considered for this protocol. Efforts will be made to enroll equal numbers of men and women for this clinical study.
Criteria

Inclusion criteria:

  • Males and females age 18 through 80 years
  • Female patients who are: surgically sterile (hysterectomy or bilateral tubule libation), at least one year post-menopausal, or have a negative pregnancy test on the day of treatment
  • Written informed consent

Exclusion Criteria:

  • Patient consumed food/beverage/medication containing caffeine/methylxanthines up to 12 hours prior to infusion
  • Exacerbation of COPD, Asthma (actively wheezing)
  • Sinus node dysfunction in absence of pacemaker
  • Use of Aggrenox (ASA/Dipyridamole), Pentoxifylline (Trental) , or oral Dipyridamole (Persantine)
  • Atrial fibrillation
  • Pregnant/breast feeding
  • Non English speaking patients
  • Subject is allergic or intolerant to aminophylline, regadenoson
  • Subject has a history of known or suspected bronchospastic lung disease [e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD, etc.)]
  • Patients with first degree or second degree AV block
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137409


Locations
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Albert Sinusas, MD Yale University
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01137409     History of Changes
Other Study ID Numbers: 0811004420
First Submitted: June 3, 2010
First Posted: June 4, 2010
Last Update Posted: May 20, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases