Coronary Artery DiseaseNCT00853671
Myocardial Stress Perfusion Imaging With Dual Source CT
A study testing Adenosine Stress Dual-source CTP in people with Coronary Artery Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators propose a novel technique using dual source multidetector computed tomography (DSCT) where information on both coronary anatomy and myocardial perfusion is obtained in a single scan. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Adenosine Stress Dual-source CTP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A prior adenosine or exercise stress SPECT exam with high likelihood of being referred to the cardiac catheterization laboratory for invasive angiogram
- Age > 40 years old
- Able to comprehend and sign the consent form.
Who cannot join
- Acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction, ST elevation myocardial infarction)
- Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)
- Premenopausal women who have a positive pregnancy test.
- Serum Creatinine level ≥1.5 mg/dl as an indicator of renal insufficiency.
- Known allergy to iodinated contrast agents
- Atrial fibrillation
Show all 10Show fewer
- Asthma
- Critical aortic stenosis
- Systolic blood pressure < 90 mmHg
- Advanced heart block
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The investigators propose a novel technique using dual source multidetector computed tomography (DSCT) where information on both coronary anatomy and myocardial perfusion is obtained in a single scan. The investigators hypothesize that a coronary CTA protocol can be devised to obtain resting myocardial perfusion, myocardial perfusion after stress, and coronary anatomy. Hence, one diagnostic test will be able to detect the presence of coronary plaque as well as assess the functional significance of a stenosis.
- Conditions
- Coronary Artery Disease
- Being tested
- Adenosine Stress Dual-source CTP
- Keywords
- Coronary Artery Disease, Multidetector Computed Tomography, Myocardial Perfusion Imaging
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenosine Stress Dual-source CTPOther
Also called Adenosine, Iopamidol 370, Siemens SOMATOM Definition
Adenosine- continuous infusion at 140mcg/ kg/ min for 2.5 min; Iopamidol (IV contrast)- total dose of 150cc; Siemens SOMATOM Definition CT scanner (CT scan radiation) - effective radiation dose of approximately 13mSv (tube voltage 120kV, tube current 340mAs for one retrospectively gated cardiac CT with tube current modulation and two prospectively gated cardiac CTs on a Dual Source scanner)
This is an observational trial, and all patients will undergo the Adenosine Stress Dual-source CTP procedure.
| Study group | Role | What they receive |
|---|---|---|
| Adenosine Stress Dual-source CTP | Experimental | A multiphase adenosine Stress Dual-source stress perfusion computed tomography imaging test, as described above, will be performed in all patients. Receives: Other: Adenosine Stress Dual-source CTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
The gold standard for abnormality by CTP is defined as a focal stenosis of >50% at quantitative analysis of invasive coronary angiography images, when performed.
Measured: 18 months
Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
The gold standard for abnormality by CTP is defined as stenosis of 50% or more at quantitative analysis of invasive coronary angiography images, when performed.
Measured: 18 months
Secondary outcomes (2)
Per-Patient Correlation Between CTP and SPECT at Stress.
Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress.
Measured: 18 months
Per-Patient Correlation Between CTP and SPECT at Rest.
Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startApr 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, Brian Burns Ghoshhajra, Massachusetts General Hospital
- Investigators
- Brian B Ghoshhajra, MD, Principal investigator, Massachusetts General HospitalRicardo C Cury, MD, Study director, Massachusetts General Hospital, Baptist Hospital, Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853671
- Sponsor's protocol ID
- DSCTSTRESS
- Status last verified
- Jun 2018
- First submitted
- 27 Feb 2009
- Last updated
- 17 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hulten EA, Bittencourt MS, Ghoshhajra B, Blankstein R. Stress CT perfusion: coupling coronary anatomy with physiology. J Nucl Cardiol. 2012 Jun;19(3):588-600. doi: 10.1007/s12350-012-9546-5.
PubMed 22456969Techasith T, Cury RC. Stress myocardial CT perfusion: an update and future perspective. JACC Cardiovasc Imaging. 2011 Aug;4(8):905-16. doi: 10.1016/j.jcmg.2011.04.017.
PubMed 21835384Blankstein R, Shturman LD, Rogers IS, Rocha-Filho JA, Okada DR, Sarwar A, Soni AV, Bezerra H, Ghoshhajra BB, Petranovic M, Loureiro R, Feuchtner G, Gewirtz H, Hoffmann U, Mamuya WS, Brady TJ, Cury RC. Adenosine-induced stress myocardial perfusion imaging using dual-source cardiac computed tomography. J Am Coll Cardiol. 2009 Sep 15;54(12):1072-84. doi: 10.1016/j.jacc.2009.06.014.
PubMed 19744616Rocha-Filho JA, Blankstein R, Shturman LD, Bezerra HG, Okada DR, Rogers IS, Ghoshhajra B, Hoffmann U, Feuchtner G, Mamuya WS, Brady TJ, Cury RC. Incremental value of adenosine-induced stress myocardial perfusion imaging with dual-source CT at cardiac CT angiography. Radiology. 2010 Feb;254(2):410-9. doi: 10.1148/radiol.09091014.
PubMed 20093513Okada DR, Ghoshhajra BB, Blankstein R, Rocha-Filho JA, Shturman LD, Rogers IS, Bezerra HG, Sarwar A, Gewirtz H, Hoffmann U, Mamuya WS, Brady TJ, Cury RC. Direct comparison of rest and adenosine stress myocardial perfusion CT with rest and stress SPECT. J Nucl Cardiol. 2010 Jan-Feb;17(1):27-37. doi: 10.1007/s12350-009-9156-z.
PubMed 19936863Uthamalingam S, Gurm GS, Sidhu MS, Verdini DJ, Vorasettakarnkij Y, Engel LC, Blankstein R, Mamuya WS, Hoffman U, Brady TJ, Cury RC, Ghoshhajra BB. Comparison of dual-source 64-slice adenosine stress CT perfusion with stress-gated SPECT-MPI for evaluation of left ventricular function and volumes. J Cardiovasc Comput Tomogr. 2012 Jan-Feb;6(1):24-30. doi: 10.1016/j.jcct.2011.10.016. Epub 2011 Nov 18.
PubMed 22222164Ghoshhajra BB, Maurovich-Horvat P, Techasith T, Medina HM, Verdini D, Sidhu MS, Blankstein R, Brady TJ, Cury RC. Infarct detection with a comprehensive cardiac CT protocol. J Cardiovasc Comput Tomogr. 2012 Jan-Feb;6(1):14-23. doi: 10.1016/j.jcct.2011.10.014. Epub 2011 Nov 18.
PubMed 22210535Ghoshhajra BB, Rogers IS, Maurovich-Horvat P, Techasith T, Verdini D, Sidhu MS, Drzezga NK, Medina HM, Blankstein R, Brady TJ, Cury RC. A comparison of reconstruction and viewing parameters on image quality and accuracy of stress myocardial CT perfusion. J Cardiovasc Comput Tomogr. 2011 Nov-Dec;5(6):459-66. doi: 10.1016/j.jcct.2011.10.011. Epub 2011 Oct 31.
PubMed 22146505
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Stress Perfusion Imaging With Dual Source CT
- ClinicalTrials.gov ID
- NCT00853671
- Acronym / sponsor ID
- DSCTSTRESS
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Multidetector Computed Tomography, Myocardial Perfusion Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Posted 17 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a novel technique using dual source multidetector computed tomography (DSCT) where information on both coronary anatomy and myocardial perfusion is obtained in a single scan. The investigators hypothesize that a coronary CTA protocol can be devised to obtain resting myocardial perfusion, myocardial perfusion after stress, and coronary anatomy. Hence, one diagnostic test will be able to detect the presence of coronary plaque as well as assess the functional significance of a stenosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adenosine Stress Dual-source CTP | Experimental | Other: Adenosine Stress Dual-source CTPA multiphase adenosine Stress Dual-source stress perfusion computed tomography imaging test, as described above, will be performed in all patients. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A prior adenosine or exercise stress SPECT exam with high likelihood of being referred to the cardiac catheterization laboratory for invasive angiogram
- Age > 40 years old
- Able to comprehend and sign the consent form.
Key exclusion criteria (10 listed)
- Acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction, ST elevation myocardial infarction)
- Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)
- Premenopausal women who have a positive pregnancy test.
- Serum Creatinine level ≥1.5 mg/dl as an indicator of renal insufficiency.
- Known allergy to iodinated contrast agents
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 |
|---|---|---|
| Adenosine Stress Dual-source CTPAlso: Adenosine, Iopamidol 370, Siemens SOMATOM DefinitionAdenosine- continuous infusion at 140mcg/ kg/ min for 2.5 min; Iopamidol (IV contrast)- total dose of 150cc; Siemens SOMATOM Definition CT scanner (CT scan radiation) - effective radiation dose of approximately 13mSv (tube voltage 120kV, tube current 340mAs for one retrospectively gated cardiac CT with tube current modulation and two prospectively gated cardiac CTs on a Dual Source scanner) This is an observational trial, and all patients will undergo the Adenosine Stress Dual-source CTP procedure. | Other | Adenosine Stress Dual-source CTP |
Primary outcome
Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
Time frame: 18 months
The gold standard for abnormality by CTP is defined as a focal stenosis of >50% at quantitative analysis of invasive coronary angiography images, when performed.
Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
Time frame: 18 months
The gold standard for abnormality by CTP is defined as stenosis of 50% or more at quantitative analysis of invasive coronary angiography images, when performed.
2 secondary outcomes
Per-Patient Correlation Between CTP and SPECT at Stress.
Time frame: 18 months
Per-Patient Correlation Between CTP and SPECT at Rest.
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22456969Hulten EA, Bittencourt MS, Ghoshhajra B, Blankstein R. Stress CT perfusion: coupling coronary anatomy with physiology. J Nucl Cardiol. 2012 Jun;19(3):588-600. doi: 10.1007/s12350-012-9546-5.
- Background: PubMed 21835384Techasith T, Cury RC. Stress myocardial CT perfusion: an update and future perspective. JACC Cardiovasc Imaging. 2011 Aug;4(8):905-16. doi: 10.1016/j.jcmg.2011.04.017.
- Results publication: PubMed 19744616Blankstein R, Shturman LD, Rogers IS, Rocha-Filho JA, Okada DR, Sarwar A, Soni AV, Bezerra H, Ghoshhajra BB, Petranovic M, Loureiro R, Feuchtner G, Gewirtz H, Hoffmann U, Mamuya WS, Brady TJ, Cury RC. Adenosine-induced stress myocardial perfusion imaging using dual-source cardiac computed tomography. J Am Coll Cardiol. 2009 Sep 15;54(12):1072-84. doi: 10.1016/j.jacc.2009.06.014.
- Results publication: PubMed 20093513Rocha-Filho JA, Blankstein R, Shturman LD, Bezerra HG, Okada DR, Rogers IS, Ghoshhajra B, Hoffmann U, Feuchtner G, Mamuya WS, Brady TJ, Cury RC. Incremental value of adenosine-induced stress myocardial perfusion imaging with dual-source CT at cardiac CT angiography. Radiology. 2010 Feb;254(2):410-9. doi: 10.1148/radiol.09091014.
- Results publication: PubMed 19936863Okada DR, Ghoshhajra BB, Blankstein R, Rocha-Filho JA, Shturman LD, Rogers IS, Bezerra HG, Sarwar A, Gewirtz H, Hoffmann U, Mamuya WS, Brady TJ, Cury RC. Direct comparison of rest and adenosine stress myocardial perfusion CT with rest and stress SPECT. J Nucl Cardiol. 2010 Jan-Feb;17(1):27-37. doi: 10.1007/s12350-009-9156-z.
- Results publication: PubMed 22222164Uthamalingam S, Gurm GS, Sidhu MS, Verdini DJ, Vorasettakarnkij Y, Engel LC, Blankstein R, Mamuya WS, Hoffman U, Brady TJ, Cury RC, Ghoshhajra BB. Comparison of dual-source 64-slice adenosine stress CT perfusion with stress-gated SPECT-MPI for evaluation of left ventricular function and volumes. J Cardiovasc Comput Tomogr. 2012 Jan-Feb;6(1):24-30. doi: 10.1016/j.jcct.2011.10.016. Epub 2011 Nov 18.
- Results publication: PubMed 22210535Ghoshhajra BB, Maurovich-Horvat P, Techasith T, Medina HM, Verdini D, Sidhu MS, Blankstein R, Brady TJ, Cury RC. Infarct detection with a comprehensive cardiac CT protocol. J Cardiovasc Comput Tomogr. 2012 Jan-Feb;6(1):14-23. doi: 10.1016/j.jcct.2011.10.014. Epub 2011 Nov 18.
- Results publication: PubMed 22146505Ghoshhajra BB, Rogers IS, Maurovich-Horvat P, Techasith T, Verdini D, Sidhu MS, Drzezga NK, Medina HM, Blankstein R, Brady TJ, Cury RC. A comparison of reconstruction and viewing parameters on image quality and accuracy of stress myocardial CT perfusion. J Cardiovasc Comput Tomogr. 2011 Nov-Dec;5(6):459-66. doi: 10.1016/j.jcct.2011.10.011. Epub 2011 Oct 31.
Related trials for Coronary Artery Disease
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
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.
Brian B Ghoshhajra, MD principal investigator
Massachusetts General Hospital
Ricardo C Cury, MD study director
Massachusetts General Hospital, Baptist Hospital, Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adenosine Stress Dual-source CTP in people with Coronary Artery Disease, run by Massachusetts General Hospital at 1 site 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 3 inclusion and 10 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 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 17 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography. (time frame: 18 months). The study lists 2 primary outcomes in all. 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 NCT00853671, which also lists 8 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 17 Dec 2018.