Myocardial IschemiaNCT01434043
Diagnostic Accuracy of Cardiac CT Perfusion Compared to PET Imaging
An observational study of Myocardial Ischemia and Coronary Artery Disease, run by University of Washington at 1 site in United States.
Trial summary
This purpose of this research project is to test the diagnostic accuracy (i.e., sensitivity, specificity, positive and negative predictive value, and receiver operator curve area under the curve) of cardiac computed tomography (CT) perfusion as compared to the best non-invasive test of blood flow -- cardiac positron… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Myocardial Ischemia, Coronary Artery Disease, Myocardial Infarction
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to 31 Dec 2019
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with suspected or known myocardial ischemia
Who may be able to join
- Patients referred for
- clinically indicated PET imaging for assessment of myocardial ischemia
- clinically indicated CCTA scanning with known coronary artery disease
- ≥20 years of age and ≤ 80 years of age
- Able to provide written informed consent
Who cannot join
- Contraindications to beta blockers or regadenoson
- Active reactive airway disease
- 2nd or 3rd degree heart block (without a pacemaker)
- Sick sinus syndrome (without a pacemaker)
- Long QT syndrome (QTC > 500 msec)
- Severe hypotension
Show all 13Show fewer
- Decompensated heart failure
- Pregnancy
- Contraindications to undergoing any CT imaging procedure with contrast:
- Irregular heart rhythm despite beta blockade
- Creatinine >1.6 mg/dl
- Allergy to iodinated contrast medium
- Inability to lie flat
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98115
About this study
This purpose of this research project is to test the diagnostic accuracy (i.e., sensitivity, specificity, positive and negative predictive value, and receiver operator curve area under the curve) of cardiac computed tomography (CT) perfusion as compared to the best non-invasive test of blood flow -- cardiac positron emission transmission (PET) perfusion imaging.
The primary outcome of the study is to determine the CT perfusion technique with the highest overall diagnostic accuracy measured by the highest area under the receiver operator curve.
Read more
The investigators will test 4 different CT perfusion techniques. (A) Qualitative, visual inspection of the contrast-enhanced CT images (B) Enhanced voxel distribution analysis (C) Rate of myocardial contrast enhancement analysis (D) Quantitative heart blood flow using a distributed 2-region analysis
A second aim is to reduce the radiation dose needed to maintain CT perfusion diagnostic accuracy. Using the CT perfusion data, the investigators will model the minimal number of cardiac cycle radiation exposures needed to keep the diagnostic accuracy similar to the full data set.
A third aim is to test the incremental diagnostic accuracy of CT angiography plus CT perfusion to identify regions of low blood flow as compared to PET perfusion alone.
Read the detailed description
Chest pain and other symptoms can occur as a result of blockages in the arteries that supply the heart; these arteries are called the "coronary arteries". Blockages in the coronary arteries may decrease blood flow and oxygen delivery to the heart muscle, causing chest pain or other "anginal" symptoms. Coronary angiography is a commonly used test to visualize coronary artery disease or blockages but may not provide all the answers physicians need to assess patients with symptoms like chest pain. Two options for coronary angiography exist, invasive angiography and cardiac computed tomography angiography (CCTA). CCTA is completed by injecting contrast into a peripheral vein (not an artery) and then imaging when the coronary arteries fill with contrast. The imaged coronary arteries may be blocked partially, completely or not at all. While a blockage that occludes greater than 70% of an artery is highly correlated with chest pain or other anginal symptoms, occlusions of 40% or more may or may not decrease heart blood flow. Often multiple imaging studies are needed to evaluate whether blood flow is decreased in the setting of partial coronary artery blockages including non-invasive heart imaging to assess heart blood flow.
One type of nuclear imaging is termed positron emission tomography (PET). In order to differentiate blockages that have poor heart perfusion with activity, nuclear PET images are taken at rest, when flow should be normal, and then repeated after the investigators "stress" the heart with medications. If blood flow is decreased during stress, a "defect" on the PET images is seen.
An alternative, non-invasive technique to test for heart blood flow/perfusion to to measure heart blood flow as computed tomography (CT) contrast goes in and comes out. Preliminary studies in animals and humans to assess heart blood flow/perfusion using contrast-enhanced cardiac CT have been promising, but further work is needed. Combining CCTA with CT blood flow/perfusion measurements in the same setting could lead to a single, accurate diagnostic test that measures coronary artery blockage as well as blood flow.
One limitation of CT imaging is the amount of radiation that can be given. The CCTA radiation dose is currently less than both nuclear PET imaging and invasive coronary angiography. However, if CT blood flow imaging is added to routine CCTA to assess heart perfusion and coronary blockages in one test, the radiation dose may be higher.
The primary purpose of this research project is to test the diagnostic accuracy of various cardiac CT perfusion techniques as compared to the best non-invasive test of blood flow, cardiac PET perfusion imaging. The investigators goal is to use the least amount of radiation to achieve a high diagnostic accuracy for CCTA as well as CT blood flow/perfusion. The investigators goal is to have CT heart blood flow/perfusion radiation doses that are the same or less than nuclear blood flow imaging. The investigators have estimated that they need as few as 4 low radiation dose images of the heart to allow accurate heart blood flow measurement.
- Keywords
- Cardiac CT perfusion, Positron emission tomography perfusion, Quantitative perfusion
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Myocardial ischemia patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy measures of cardiac CT perfusion techniques
Diagnostic performance includes sensitivity, specificity, positive and negative predictive values, and receiver operator curve area under the curve [ROC AUC]. The highest ROC AUC will be considered the best diagnostic performance and will be compared statisically using the c-statistic.
Measured: 1 month
Secondary outcomes (2)
Minimal number of images needed for CT perfusion
Using modeling techniques, we will determine the least number of images needed for each CT perfusion technique to maintain diagnostic accuracy. The fewer number of images will correspond to a lower radiation dose.
Measured: 1 month
Diagnostic accuracy of CCTA and CT perfusion compared to PET perfusion imaging alone
Incremental diagnostic accuracy changes with CCTA + CT perfusion compared to PET perfusion alone.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startSep 2011
- Primary completion31 Dec 2017
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelley Branch, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434043
- Sponsor's protocol ID
- STUDY00001616
- Status last verified
- May 2023
- First submitted
- 9 Sep 2011
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Cardiac CT Perfusion Compared to PET Imaging
- ClinicalTrials.gov ID
- NCT01434043
- Acronym / sponsor ID
- STUDY00001616
- Keywords
- Cardiac CT perfusion, Positron emission tomography perfusion, Quantitative perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 14 Sep 2011 (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.
This purpose of this research project is to test the diagnostic accuracy (i.e., sensitivity, specificity, positive and negative predictive value, and receiver operator curve area under the curve) of cardiac computed tomography (CT) perfusion as compared to the best non-invasive test of blood flow -- cardiac positron emission transmission (PET) perfusion imaging.
The primary outcome of the study is to determine the CT perfusion technique with the highest overall diagnostic accuracy measured by the highest area under the receiver operator curve.
The investigators will test 4 different CT perfusion techniques. (A) Qualitative, visual inspection of the contrast-enhanced CT images (B) Enhanced voxel distribution analysis (C) Rate of myocardial contrast enhancement analysis (D) Quantitative heart blood flow using a distributed 2-region analysis
A second aim is to reduce the radiation dose needed to maintain CT perfusion diagnostic accuracy. Using the CT perfusion data, the investigators will model the minimal number of cardiac cycle radiation exposures needed to keep the diagnostic accuracy similar to the full data set.
A third aim is to test the incremental diagnostic accuracy of CT angiography plus CT perfusion to identify regions of low blood flow as compared to PET perfusion alone.
Detailed description
Chest pain and other symptoms can occur as a result of blockages in the arteries that supply the heart; these arteries are called the "coronary arteries". Blockages in the coronary arteries may decrease blood flow and oxygen delivery to the heart muscle, causing chest pain or other "anginal" symptoms. Coronary angiography is a commonly used test to visualize coronary artery disease or blockages but may not provide all the answers physicians need to assess patients with symptoms like chest pain. Two options for coronary angiography exist, invasive angiography and cardiac computed tomography angiography (CCTA). CCTA is completed by injecting contrast into a peripheral vein (not an artery) and then imaging when the coronary arteries fill with contrast. The imaged coronary arteries may be blocked partially, completely or not at all. While a blockage that occludes greater than 70% of an artery is highly correlated with chest pain or other anginal symptoms, occlusions of 40% or more may or may not decrease heart blood flow. Often multiple imaging studies are needed to evaluate whether blood flow is decreased in the setting of partial coronary artery blockages including non-invasive heart imaging to assess heart blood flow.
One type of nuclear imaging is termed positron emission tomography (PET). In order to differentiate blockages that have poor heart perfusion with activity, nuclear PET images are taken at rest, when flow should be normal, and then repeated after the investigators "stress" the heart with medications. If blood flow is decreased during stress, a "defect" on the PET images is seen.
An alternative, non-invasive technique to test for heart blood flow/perfusion to to measure heart blood flow as computed tomography (CT) contrast goes in and comes out. Preliminary studies in animals and humans to assess heart blood flow/perfusion using contrast-enhanced cardiac CT have been promising, but further work is needed. Combining CCTA with CT blood flow/perfusion measurements in the same setting could lead to a single, accurate diagnostic test that measures coronary artery blockage as well as blood flow.
One limitation of CT imaging is the amount of radiation that can be given. The CCTA radiation dose is currently less than both nuclear PET imaging and invasive coronary angiography. However, if CT blood flow imaging is added to routine CCTA to assess heart perfusion and coronary blockages in one test, the radiation dose may be higher.
The primary purpose of this research project is to test the diagnostic accuracy of various cardiac CT perfusion techniques as compared to the best non-invasive test of blood flow, cardiac PET perfusion imaging. The investigators goal is to use the least amount of radiation to achieve a high diagnostic accuracy for CCTA as well as CT blood flow/perfusion. The investigators goal is to have CT heart blood flow/perfusion radiation doses that are the same or less than nuclear blood flow imaging. The investigators have estimated that they need as few as 4 low radiation dose images of the heart to allow accurate heart blood flow measurement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myocardial ischemia patients | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with suspected or known myocardial ischemia
Key inclusion criteria (5 listed)
- Patients referred for
- ≥20 years of age and ≤ 80 years of age
- Able to provide written informed consent
Key exclusion criteria (13 listed)
- Contraindications to beta blockers or regadenoson
- Pregnancy
- Contraindications to undergoing any CT imaging procedure with contrast:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy measures of cardiac CT perfusion techniques
Time frame: 1 month
Diagnostic performance includes sensitivity, specificity, positive and negative predictive values, and receiver operator curve area under the curve [ROC AUC]. The highest ROC AUC will be considered the best diagnostic performance and will be compared statisically using the c-statistic.
2 secondary outcomes
Minimal number of images needed for CT perfusion
Time frame: 1 month
Diagnostic accuracy of CCTA and CT perfusion compared to PET perfusion imaging alone
Time frame: 1 month
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 9 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia and Coronary Artery Disease, run by University of Washington 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 5 inclusion and 13 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 9 May 2023. 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?
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?
Diagnostic accuracy measures of cardiac CT perfusion techniques (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2023.