Detecting Heart Disease Using First Pass Imaging With Gated SPECT Perfusion

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01137409
First received: June 3, 2010
Last updated: June 16, 2014
Last verified: June 2014
  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
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 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: Yale University
ClinicalTrials.gov Identifier: NCT01137409     History of Changes
Other Study ID Numbers: 0811004420
Study First Received: June 3, 2010
Last Updated: June 16, 2014
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 July 24, 2014