Coronary Artery DiseasePETvsSPECTNCT01179230
Rubidium-82 Position Emission Computed Tomography (PET) Versus Gated, Rest / Stress Technetium 99-m SPECT
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Hartford Hospital at 5 sites in United States.
Trial summary
Many stress tests being done today have two parts, the stress test and the pictures of your heart. The investigators are comparing a newer technique to obtain the pictures (PET imaging) to the standard method (SPECT imaging). However, it is not known if the new test is better than the old test. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia, Heart Disease
- What is being tested?
- SPECT imaging and PET imaging
- How many people
- 136 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2005to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intermediate to high likelihood of CAD referred for cardiac catheterization, either on outpatient or inpatient basis
Who may be able to join
- referred for clinical cardiac catheterization
Who cannot join
- previous CABG
- previous MI
- Asthma or obstructive airway disease
- Intolerance to Dipyridamole
- Moderate to severe valvular disease
- Cardiomyopathy - (ejection fraction less than 45%)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ohio Health Research Institute
Columbus, Ohio, 43214
Sanford Health Clinical Research
Fargo, North Dakota, 58122-0011
Hartford Hospital
Hartford, Connecticut, 06102-5037
The Heart Center, PC
Huntsville, Alabama, 35801
Cardiovascular Imaging Technologies, LLC
Kansas City, Missouri, 64111
About this study
Official title: A Prospective Comparison of Gated, Rest/Stress Rubidium-82 Position Emission Computed Tomography (PET) vs. Gated, Rest / Stress Technetium 99-m SPECT
Many stress tests being done today have two parts, the stress test and the pictures of your heart. The investigators are comparing a newer technique to obtain the pictures (PET imaging) to the standard method (SPECT imaging). However, it is not known if the new test is better than the old test. It is important to have a standard to compare these tests to, and that is why people who will be getting a cardiac catheterization are being asked to participate. The information about your arteries from the cardiac catheterization will be used to judge which stress test is better. The investigators hypothesize that the newer method (PET imaging) will be more accurate than the old method (SPECT) in detecting heart disease.
Read the detailed description
A SPECT rest image will be obtained using a technetium based isotope. On a separate day, a Rubidium rest PET image will be obtained prior to a Dipyridamole stress test. Subjects will receive both Rubidium and technetium isotopes following the Dipyridamole stress, and will undergo first PET imaging and later SPECT imaging following the stress test. Patients will then go for cardiac catheterization as clinically ordered by their physician.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Heart Disease
- Being tested
- SPECT imaging, PET imaging
- Keywords
- CAD, chest pain, acute coronary syndrome, Myocardial perfusion imaging
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Heart Diseases, Chest Pain, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT imagingOther
Also called Pharmacological stress testing, Myocardial perfusion imaging, Persantine stress test
Dipyridamole stress testing 0.57 mg/kg
PET imagingOther
Also called PET perfusion images, Rb-92, PET persantine stress test
Dipyridamole stress test 0.57 mg/kg with Rubidium PET images
| Study group | Role | What they receive |
|---|---|---|
| PET SPECT | Subjects will have both types of imaging performed, PET and SPECT Receives: Other: SPECT imaging; Other: PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Artery Disease
Measured: 30 days
Secondary outcomes (1)
Myocardial Ischemia
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startJan 2005
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bracco Diagnostics, Inc
- Responsible party
- Sponsor
- Investigators
- Gary V. Heller, M.D., Ph.D., Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179230
- Sponsor's protocol ID
- HELL001671HE
- Acronym
- PETvsSPECT
- Status last verified
- Jul 2012
- First submitted
- 8 Jun 2010
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bateman TM, Heller GV, McGhie AI, Friedman JD, Case JA, Bryngelson JR, Hertenstein GK, Moutray KL, Reid K, Cullom SJ. Diagnostic accuracy of rest/stress ECG-gated Rb-82 myocardial perfusion PET: comparison with ECG-gated Tc-99m sestamibi SPECT. J Nucl Cardiol. 2006 Jan-Feb;13(1):24-33. doi: 10.1016/j.nuclcard.2005.12.004.
PubMed 16464714Freedman N, Schechter D, Klein M, Marciano R, Rozenman Y, Chisin R. SPECT attenuation artifacts in normal and overweight persons: insights from a retrospective comparison of Rb-82 positron emission tomography and TI-201 SPECT myocardial perfusion imaging. Clin Nucl Med. 2000 Dec;25(12):1019-23. doi: 10.1097/00003072-200012000-00014.
PubMed 11129138Stewart RE, Schwaiger M, Molina E, Popma J, Gacioch GM, Kalus M, Squicciarini S, al-Aouar ZR, Schork A, Kuhl DE. Comparison of rubidium-82 positron emission tomography and thallium-201 SPECT imaging for detection of coronary artery disease. Am J Cardiol. 1991 Jun 15;67(16):1303-10. doi: 10.1016/0002-9149(91)90456-u.
PubMed 2042560Go RT, Marwick TH, MacIntyre WJ, Saha GB, Neumann DR, Underwood DA, Simpfendorfer CC. A prospective comparison of rubidium-82 PET and thallium-201 SPECT myocardial perfusion imaging utilizing a single dipyridamole stress in the diagnosis of coronary artery disease. J Nucl Med. 1990 Dec;31(12):1899-905.
PubMed 2266384
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Gated, Rest/Stress Rubidium-82 Position Emission Computed Tomography (PET) vs. Gated, Rest / Stress Technetium 99-m SPECT
- ClinicalTrials.gov ID
- NCT01179230
- Acronym / sponsor ID
- PETvsSPECT / HELL001671HE
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Heart Disease
- Keywords
- CAD, chest pain, acute coronary syndrome, Myocardial perfusion imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- Bracco Diagnostics, Inc
- Study start
- Jan 2005
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many stress tests being done today have two parts, the stress test and the pictures of your heart. The investigators are comparing a newer technique to obtain the pictures (PET imaging) to the standard method (SPECT imaging). However, it is not known if the new test is better than the old test. It is important to have a standard to compare these tests to, and that is why people who will be getting a cardiac catheterization are being asked to participate. The information about your arteries from the cardiac catheterization will be used to judge which stress test is better. The investigators hypothesize that the newer method (PET imaging) will be more accurate than the old method (SPECT) in detecting heart disease.
Detailed description
A SPECT rest image will be obtained using a technetium based isotope. On a separate day, a Rubidium rest PET image will be obtained prior to a Dipyridamole stress test. Subjects will receive both Rubidium and technetium isotopes following the Dipyridamole stress, and will undergo first PET imaging and later SPECT imaging following the stress test. Patients will then go for cardiac catheterization as clinically ordered by their physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET SPECT | – | Other: SPECT imaging, Other: PET imagingSubjects will have both types of imaging performed, PET and SPECT |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intermediate to high likelihood of CAD referred for cardiac catheterization, either on outpatient or inpatient basis
Key inclusion criteria (1 listed)
- referred for clinical cardiac catheterization
Key exclusion criteria (6 listed)
- previous CABG
- previous MI
- Asthma or obstructive airway disease
- Intolerance to Dipyridamole
- Moderate to severe valvular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPECT imagingAlso: Pharmacological stress testing, Myocardial perfusion imaging, Persantine stress testDipyridamole stress testing 0.57 mg/kg | Other | PET SPECT |
| PET imagingAlso: PET perfusion images, Rb-92, PET persantine stress testDipyridamole stress test 0.57 mg/kg with Rubidium PET images | Other | PET SPECT |
Primary outcome
Coronary Artery Disease
Time frame: 30 days
1 secondary outcome
Myocardial Ischemia
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
- Background: PubMed 16464714Bateman TM, Heller GV, McGhie AI, Friedman JD, Case JA, Bryngelson JR, Hertenstein GK, Moutray KL, Reid K, Cullom SJ. Diagnostic accuracy of rest/stress ECG-gated Rb-82 myocardial perfusion PET: comparison with ECG-gated Tc-99m sestamibi SPECT. J Nucl Cardiol. 2006 Jan-Feb;13(1):24-33. doi: 10.1016/j.nuclcard.2005.12.004.
- Background: PubMed 11129138Freedman N, Schechter D, Klein M, Marciano R, Rozenman Y, Chisin R. SPECT attenuation artifacts in normal and overweight persons: insights from a retrospective comparison of Rb-82 positron emission tomography and TI-201 SPECT myocardial perfusion imaging. Clin Nucl Med. 2000 Dec;25(12):1019-23. doi: 10.1097/00003072-200012000-00014.
- Background: PubMed 2042560Stewart RE, Schwaiger M, Molina E, Popma J, Gacioch GM, Kalus M, Squicciarini S, al-Aouar ZR, Schork A, Kuhl DE. Comparison of rubidium-82 positron emission tomography and thallium-201 SPECT imaging for detection of coronary artery disease. Am J Cardiol. 1991 Jun 15;67(16):1303-10. doi: 10.1016/0002-9149(91)90456-u.
- Background: PubMed 2266384Go RT, Marwick TH, MacIntyre WJ, Saha GB, Neumann DR, Underwood DA, Simpfendorfer CC. A prospective comparison of rubidium-82 PET and thallium-201 SPECT myocardial perfusion imaging utilizing a single dipyridamole stress in the diagnosis of coronary artery disease. J Nucl Med. 1990 Dec;31(12):1899-905.
Related trials for Coronary Artery Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary V. Heller, M.D., Ph.D. principal investigator
Hartford Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Hartford Hospital at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary Artery Disease (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01179230, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.