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Detecting Heart Disease Using First Pass Imaging With Gated SPECT Perfusion

This study has been completed.
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Yale University Identifier:
First received: June 3, 2010
Last updated: May 19, 2015
Last verified: May 2015
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.

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)
Suspected or Diagnosed with Coronary artery disease
All patients with suspected or previously diagnosed coronary artery disease

  Show Detailed Description


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01137409

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

Responsible Party: Yale University Identifier: NCT01137409     History of Changes
Other Study ID Numbers: 0811004420
Study First Received: June 3, 2010
Last Updated: May 19, 2015

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases processed this record on May 25, 2017