Detecting Heart Disease Using First Pass Imaging With Gated SPECT Perfusion

NCT01137409 | Completed

• 1 other identifier: 0811004420
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

  First pass imaging will be done in conjunction with the clinically indicated SPECT study.

  First pass imaging done in conjunction with SPECT study

Secondary Outcomes (1)

• 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

  Immediately following administration of regadenoson.

Study Arms (1)

Suspected or Diagnosed with Coronary artery disease

All patients with suspected or previously diagnosed coronary artery disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Albert Sinusas, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 4, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2014
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

US (1)