Coronary Artery DiseaseNCT04221594
Quantification of Myocardial Blood Flow Using Dynamic PET/CTA Fused Imagery
An observational study of Coronary Artery Disease, run by Emory University at 6 sites in 2 countries.
Trial summary
This observational prospective clinical study is to develop software tools to fuse coronary anatomy data obtained from CT coronary angiography with dynamic PET data to noninvasively measure absolute myocardial blood flow, flow reserve and relative flow reserve across specific coronary lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Invasive Cardiac Catheterization (ICA), Coronary Computed Tomographic Angiogram (CCTA) and Dynamic Cardiac Positron Emission Tomography (dPET)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 68 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Nov 2019to 30 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with angina referred to an initial imaging test for the assessment of CAD will be screened and considered for inclusion in the study. Different hospital policies and guidelines determine which initial test is commonly requested: at Emory University Hospital patients who underwent a dPET will be considered for enrollment; at the South Korean centers patients who received a CTA will be screened. Depending on test results, patients who are referred to undergo a cardiac catheterization, will be invited to participate in the study.
Who may be able to join
- Adult (≥18 years of age) - as the research topic to be studied is irrelevant to children
- Written consent form
- Patients with prior dynamic PET or CCTA or ICA for any indications
Who cannot join
- Previous history of allergy to iodinated contrast
- Previous CABG
- Serum creatinine levels >1.8 mg/dl unless patient has end stage kidney disease, not producing any urine and dialysis
- History of claustrophobia (CT tunnel length of more than 100 cm)
- Significant arrhythmias or tachycardia
- History of frequent asthma attacks or acting wheezing
Show all 12Show fewer
- Second- and third-degree heart block
- Systolic blood pressure of < 90 mmHg
- Heart failure with NYHA class III-IV at the time of the CCTA procedure. If it is deemed that, the heart failure has been resolved or the patient was incorrectly labeled as having heart failure the radiology physician in charge will verify the absence of Heart Failure at the time of CCTA and perform the procedure.
- Recent myocardial infarction
- If the patient has been diagnosed with unstable angina within 24 hours prior to CCTA, the patient will not be consented. If the patient does not have the diagnosis of unstable angina and is consented, the radiology physician in charge will verify the absence of unstable angina at the time of CCTA.
- Patients enrolled and consented for the invasive measurements that at the time of catheterization exhibit severe vessel disease and/or obstructions that prevent the operator from safely conducting the measurements will be removed from the study; further research imaging sessions - if planned - will be canceled and patients indicated as "screen failure" in our enrollment log.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites
Emory Clinic
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
Saint Francis Hospital & Heart Center
Roslyn, New York, 11576
South Korea3 sites
Chonnam National University
Gwangju
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: Quantification of Myocardial Blood Flow Using Dynamic PET/CTA Fused Imagery to Determine the Physiological Significance of Specific Coronary Lesions.
This observational prospective clinical study is to develop software tools to fuse coronary anatomy data obtained from CT coronary angiography with dynamic PET data to noninvasively measure absolute myocardial blood flow, flow reserve and relative flow reserve across specific coronary lesions. Results will be compared to those obtained invasively in the catheterization laboratory.
Read the detailed description
This observational prospective clinical study is to develop software tools to fuse coronary anatomy data obtained from CT coronary angiography with dynamic PET data to noninvasively measure absolute myocardial blood flow, flow reserve and relative flow reserve across specific coronary lesions. These results will be compared to those obtained invasively in the catheterization laboratory. The long-term objective of the study is to improve the care of cardiac patients by developing, validating and implementing clinically computer-based methods to noninvasively determine the physiological significance of specific coronary lesions using methods to fuse and quantify multi-modality cardiac imagery.
- Conditions
- Coronary Artery Disease
- Being tested
- Invasive Cardiac Catheterization (ICA), Coronary Computed Tomographic Angiogram (CCTA), Dynamic Cardiac Positron Emission Tomography (dPET)
- Keywords
- Fractional flow reserve, Myocardial blood flow, Relative flow reserve, Non-invasive measure, Cardiac catheterization, CT coronary angiography, Dynamic PET, Invasive coronary angiography, 3D fusion dPET/CTA, FFRCT
- 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.
Invasive Cardiac Catheterization (ICA)Procedure or surgery
Invasive functional measurements will be performed to assess the functional significance of specific lesions by means of FFR and CFR, and to test the presence of microvascular disease by means of IMR in all vessels for which the procedures are feasible. In summary, a 5- to 7-F guide catheter without side holes is used to engage the coronary artery and a pressure-temperature sensor-tipped guidewire introduced. The pressure sensor is positioned at the distal segment of a target vessel, and intracoronary nitroglycerine (100-200 mg) administered before each measurement. The best systolic and diastolic phase (located between 30-50%, and 60-75% of the cardiac cycle) will be selected for successive processing as it allows a relative motion free visualization of the main vessels and the myocardium.
Coronary Computed Tomographic Angiogram (CCTA)Procedure or surgery
Fasting patients will undergo a test for coronary calcium by CT; calcium scoring analysis will be done post image data acquisition using the manufacturer's software. Nitroglycerine will be administered in all patients (sublingual administration prior to CCTA initiation). CT acquisitions will be prospectively ECG-gated (30-80% of the cardiac cycle). The acquisition begins with a scout scan to identify the borders of the heart to minimize the field of view and exposure to the patient. A bolus of 60 mL nonionic contrast agent is then injected followed by 60 mL of saline at a rate of 4 mL/s to enhance signal from coronary arteries and blood chambers. In case of irregular heart rate, beta-blockers can be provided to keep optimal heart rate ~65-70 bpm. Trans-axial images are reconstructed by means of a filtered back-projection algorithm.
Dynamic Cardiac Positron Emission Tomography (dPET)Procedure or surgery
Patients will be asked to fast for 24 hours prior to the test. Before the resting perfusion phase, a single low-dose CT-based transmission scan is acquired for attenuation correction (AC) of all subsequent acquisitions. AC-CT images are automatically registered to the perfusion images, visually verified and manually corrected if necessary. Resting perfusion imaging started with the intravenous injection of a single bolus of 82Rb. Pharmacological stress imaging is obtained after adenosine infusion (140 μg/kg/min) through a peripheral vein, followed by a second dose of 82Rb. Image reconstruction is achieved by means of ordered subset expectation maximization (OSEM) iterative method. The hemodynamic responses to rest/stress tests are collected in terms of mean heart rate, mean blood systolic pressures and diastolic at rest and stress. Dynamic, gated and ungated trans-axial reconstructions are saved in DICOM format for further analysis and processing.
| Study group | Role | What they receive |
|---|---|---|
| CAD detection/risk assessment | Patients with angina referred for the assessment of CAD will undergo imaging studies to develop tools to fuse coronary anatomic data obtained from CCTA with dPET data to non-invasively measure absolute MBF, MFR and RFR along vessels centerlines and across coronary lesions. Receives: Procedure: Invasive Cardiac Catheterization (ICA); Procedure: Coronary Computed Tomographic Angiogram (CCTA); Procedure: Dynamic Cardiac Positron Emission Tomography (dPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches
Myocardial blood flow (MBF) measured in milliliters per minute per gram of tissue is providing unique pathophysiologic and diagnostic information on the function of the coronary macro- and microcirculation.
Measured: Up to 3 months
Vessel-specific quantification of myocardial blood flow RFR
Ratio of absolute hyperemic MBFs (abnormal / normal) measured in mL/min/g.
Measured: Up to 3 months
Secondary outcomes (6)
Absolute myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches
Absolute myocardial blood flow (MBF) measured in ml/min/gm provides incremental diagnostic and prognostic information over relative perfusion alone.
Measured: Up to 3 months
Myocardial flow reserve (MFR) measurement comparing non-invasive to the traditional approaches
Myocardial flow reserve (MFR) provide incremental diagnostic and prognostic information over relative perfusion alone.
Measured: Up to 3 months
Fractional Flow Reserve (FFR) measurement comparing non-invasive to the traditional approaches
FFR calculates the maximum flow down a vessel in the presence of stenosis compared to maximum flow in the hypothetical absence of the stenosis.
Measured: Up to 3 months
Stress myocardial blood flow (sMBF)/Regional myocardial blood flow (rMBF) ratio
Stress myocardial blood flow (sMBF)/Regional myocardial blood flow (rMBF) ratio will be calculated
Measured: Up to 3 months
Distal/proximal pressure ratio
Distal/proximal pressure ratio will be calculated
Measured: Up to 3 months
Discriminatory power of dPET/CTA. And FFR(CTA)
Predictive discriminatory power of each technique will be compared to ICA (FFR)
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Nov 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Emory UniversityThe 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Seoul National University, Chonnam National University Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Marina Piccinelli, Emory University
- Investigators
- Marina Piccinelli, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221594
- Sponsor's protocol ID
- IRB00107151
- Other IDs
- 1R01HL143350-01
- Status last verified
- Sep 2023
- First submitted
- 6 Jan 2020
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All PET imaging data, All CTA imaging data, Invasive Coronary Angiography (ICA) static images used for measurements, all processing and measurements made from all imaging data, patient pertinent demographics and clinical data, as well as dictionary of database formats will be shared.
Publications
AlBadri A, Piccinelli M, Cho SG, Lee JM, Jaber W, De Cecco CN, Samady H, Koo BK, Bom HS, Garcia EV. Rationale and design of the quantification of myocardial blood flow using dynamic PET/CTA-fused imagery (DEMYSTIFY) to determine physiological significance of specific coronary lesions. J Nucl Cardiol. 2020 Jun;27(3):1030-1039. doi: 10.1007/s12350-020-02052-0. Epub 2020 Feb 5.
PubMed 32026327
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Myocardial Blood Flow Using Dynamic PET/CTA Fused Imagery to Determine the Physiological Significance of Specific Coronary Lesions.
- ClinicalTrials.gov ID
- NCT04221594
- Acronym / sponsor ID
- IRB00107151
- Conditions
- Coronary Artery Disease
- Keywords
- Fractional flow reserve, Myocardial blood flow, Relative flow reserve, Non-invasive measure, Cardiac catheterization, CT coronary angiography, Dynamic PET, Invasive coronary angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Seoul National University, Chonnam National University Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 9 Jan 2020 (actual)
- 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 observational prospective clinical study is to develop software tools to fuse coronary anatomy data obtained from CT coronary angiography with dynamic PET data to noninvasively measure absolute myocardial blood flow, flow reserve and relative flow reserve across specific coronary lesions. Results will be compared to those obtained invasively in the catheterization laboratory.
Detailed description
This observational prospective clinical study is to develop software tools to fuse coronary anatomy data obtained from CT coronary angiography with dynamic PET data to noninvasively measure absolute myocardial blood flow, flow reserve and relative flow reserve across specific coronary lesions. These results will be compared to those obtained invasively in the catheterization laboratory. The long-term objective of the study is to improve the care of cardiac patients by developing, validating and implementing clinically computer-based methods to noninvasively determine the physiological significance of specific coronary lesions using methods to fuse and quantify multi-modality cardiac imagery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAD detection/risk assessment | – | Procedure: Invasive Cardiac Catheterization (ICA), Procedure: Coronary Computed Tomographic Angiogram (CCTA), Procedure: Dynamic Cardiac Positron Emission Tomography (dPET)Patients with angina referred for the assessment of CAD will undergo imaging studies to develop tools to fuse coronary anatomic data obtained from CCTA with dPET data to non-invasively measure absolute MBF, MFR and RFR along vessels centerlines and across coronary lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with angina referred to an initial imaging test for the assessment of CAD will be screened and considered for inclusion in the study. Different hospital policies and guidelines determine which initial test is commonly requested: at Emory University Hospital patients who underwent a dPET will be considered for enrollment; at the South Korean centers patients who received a CTA will be screened. Depending on test results, patients who are referred to undergo a cardiac catheterization, will be invited to participate in the study.
Key inclusion criteria (3 listed)
- Adult (≥18 years of age) - as the research topic to be studied is irrelevant to children
- Written consent form
- Patients with prior dynamic PET or CCTA or ICA for any indications
Key exclusion criteria (12 listed)
- Previous history of allergy to iodinated contrast
- Previous CABG
- Serum creatinine levels >1.8 mg/dl unless patient has end stage kidney disease, not producing any urine and dialysis
- History of claustrophobia (CT tunnel length of more than 100 cm)
- Significant arrhythmias or tachycardia
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 |
|---|---|---|
| Invasive Cardiac Catheterization (ICA)Invasive functional measurements will be performed to assess the functional significance of specific lesions by means of FFR and CFR, and to test the presence of microvascular disease by means of IMR in all vessels for which the procedures are feasible. In summary, a 5- to 7-F guide catheter without side holes is used to engage the coronary artery and a pressure-temperature sensor-tipped guidewire introduced. The pressure sensor is positioned at the distal segment of a target vessel, and intracoronary nitroglycerine (100-200 mg) administered before each measurement. The best systolic and diastolic phase (located between 30-50%, and 60-75% of the cardiac cycle) will be selected for successive processing as it allows a relative motion free visualization of the main vessels and the myocardium. | Procedure or surgery | CAD detection/risk assessment |
| Coronary Computed Tomographic Angiogram (CCTA)Fasting patients will undergo a test for coronary calcium by CT; calcium scoring analysis will be done post image data acquisition using the manufacturer's software. Nitroglycerine will be administered in all patients (sublingual administration prior to CCTA initiation). CT acquisitions will be prospectively ECG-gated (30-80% of the cardiac cycle). The acquisition begins with a scout scan to identify the borders of the heart to minimize the field of view and exposure to the patient. A bolus of 60 mL nonionic contrast agent is then injected followed by 60 mL of saline at a rate of 4 mL/s to enhance signal from coronary arteries and blood chambers. In case of irregular heart rate, beta-blockers can be provided to keep optimal heart rate ~65-70 bpm. Trans-axial images are reconstructed by means of a filtered back-projection algorithm. | Procedure or surgery | CAD detection/risk assessment |
| Dynamic Cardiac Positron Emission Tomography (dPET)Patients will be asked to fast for 24 hours prior to the test. Before the resting perfusion phase, a single low-dose CT-based transmission scan is acquired for attenuation correction (AC) of all subsequent acquisitions. AC-CT images are automatically registered to the perfusion images, visually verified and manually corrected if necessary. Resting perfusion imaging started with the intravenous injection of a single bolus of 82Rb. Pharmacological stress imaging is obtained after adenosine infusion (140 μg/kg/min) through a peripheral vein, followed by a second dose of 82Rb. Image reconstruction is achieved by means of ordered subset expectation maximization (OSEM) iterative method. The hemodynamic responses to rest/stress tests are collected in terms of mean heart rate, mean blood systolic pressures and diastolic at rest and stress. Dynamic, gated and ungated trans-axial reconstructions are saved in DICOM format for further analysis and processing. | Procedure or surgery | CAD detection/risk assessment |
Primary outcome
Myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches
Time frame: Up to 3 months
Myocardial blood flow (MBF) measured in milliliters per minute per gram of tissue is providing unique pathophysiologic and diagnostic information on the function of the coronary macro- and microcirculation.
Vessel-specific quantification of myocardial blood flow RFR
Time frame: Up to 3 months
Ratio of absolute hyperemic MBFs (abnormal / normal) measured in mL/min/g.
6 secondary outcomes
Absolute myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches
Time frame: Up to 3 months
Myocardial flow reserve (MFR) measurement comparing non-invasive to the traditional approaches
Time frame: Up to 3 months
Fractional Flow Reserve (FFR) measurement comparing non-invasive to the traditional approaches
Time frame: Up to 3 months
Stress myocardial blood flow (sMBF)/Regional myocardial blood flow (rMBF) ratio
Time frame: Up to 3 months
Distal/proximal pressure ratio
Time frame: Up to 3 months
Discriminatory power of dPET/CTA. And FFR(CTA)
Time frame: Up to 3 months
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 2 Oct 2023.
- Derived from this study: PubMed 32026327AlBadri A, Piccinelli M, Cho SG, Lee JM, Jaber W, De Cecco CN, Samady H, Koo BK, Bom HS, Garcia EV. Rationale and design of the quantification of myocardial blood flow using dynamic PET/CTA-fused imagery (DEMYSTIFY) to determine physiological significance of specific coronary lesions. J Nucl Cardiol. 2020 Jun;27(3):1030-1039. doi: 10.1007/s12350-020-02052-0. Epub 2020 Feb 5.
- Individual participant dataSharing planned: Yes. All PET imaging data, All CTA imaging data, Invasive Coronary Angiography (ICA) static images used for measurements, all processing and measurements made from all imaging data, patient pertinent demographics and clinical data, as well as dictionary of database formats will be shared.
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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.
Marina Piccinelli, PhD principal investigator
Emory University
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Emory University at 6 sites in 2 countries.
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 12 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 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, South Korea. 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?
Myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches (time frame: Up to 3 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 NCT04221594, which also lists 1 linked publication.
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 2 Oct 2023.