Detecting Heart Disease Using First Pass Imaging With Gated SPECT Perfusion

This study is currently recruiting participants.
Verified August 2010 by Yale University
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Albert Sinusas, Yale University
ClinicalTrials.gov Identifier:
NCT01137409
First received: June 3, 2010
Last updated: January 29, 2013
Last verified: August 2010
  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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Echocardiography will be done immediately following the administration of regadenoson.


Estimated Enrollment: 200
Study Start Date: August 2010
Estimated Primary Completion Date: December 2016 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137409

Locations
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Donna Natale, BS    203-785-5005    donna.natale@yale.edu   
Principal Investigator: Albert J Sinusas, MD         
Sponsors and Collaborators
Yale University
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Albert Sinusas, MD Yale University
  More Information

No publications provided

Responsible Party: Albert Sinusas, Professor, Yale University
ClinicalTrials.gov Identifier: NCT01137409     History of Changes
Other Study ID Numbers: 0811004420
Study First Received: June 3, 2010
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 22, 2014