Detecting Heart Disease Using First Pass Imaging With Gated SPECT Perfusion
This study is currently recruiting participants.
Verified August 2010 by Yale University
Sponsor:
Yale University
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
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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 June 18, 2013