Coronary Artery DiseaseNCT01719016
Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics
An observational study of Coronary Artery Disease, run by University of Cincinnati at 1 site in United States.
Trial summary
Diagnosis of relative contributions of large artery blockages and microvascular blockages is very much needed in the treatment of coronary artery disease. In order to achieve this, two novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings and Lesion flow coefficient (LFC), which… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiac PET, Coronary catheterization
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chest pain and suspected ischemia that needs to be assessed by a stress test
Who may be able to join
- 18 years of age or above
- Patients referred to a stress test by a Cardiologist
- Acute Chest pain, as per patient input.
- Risk Assessment with prior test results and/or previous history of known chronic stable CAD.
- Borderline or discordant stress testing where obstructive CAD remains a concern.
- New or worsening symptoms- Abnormal coronary angiography or abnormal prior stress imaging study.
- Coronary stenosis or anatomic abnormality of uncertain significance.
- In absence of reliable diagnostic information from another imaging modality.
Who cannot join
- Left ventricular ejection fraction less the 25% determined by gated SPECT imaging
- Non-dialysis dependent chronic kidney disease with baseline serum creatinine greater than 2.5 gm/dL.
- History of type II heparin-induced thrombocytopenia.
- Significant co-morbid condition that is medically unstable and would make coronary angiography prohibitive or contraindicated.
- Pregnant women.
- Incapacitated for Consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Veteran Affairs Medical Center
Cincinnati, Ohio, 45220
About this study
Diagnosis of relative contributions of large artery blockages and microvascular blockages is very much needed in the treatment of coronary artery disease. In order to achieve this, two novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with pressure and flow readings, are being investigated.
Read the detailed description
Diagnosis of relative contributions of large artery blockages and microvascular blockages is very much needed in the treatment of coronary artery disease. In order to achieve this, two novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with pressure and flow readings, are being investigated. The diagnostic parameters will be correlated with Coronary Flow Reserve (CFR)values obtained using Positron Emission Tomography (PET) imaging. They will also be correlated with Fractional Flow Reserve (FFR).
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiac PET, Coronary catheterization
- Keywords
- Reversible ischemia, microvascular dysfunction
- 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.
Cardiac PET, Coronary catheterizationProcedure or surgery
Also called Volcano therapeutics, Combomap machine, Adenosine, Lexiscan
Patients would under go a Cardiac rest and stress PET scan and include the following drug administration:
- N-13 Ammonia radionuclide - Two doses, 10 mCi for rest, 20 mCi for stress
- Lexiscan - stress agent for PET scan
Patients would also undergo Coronary catheterization including the following drug administration and device usage:
- Combowire to obtain pressure and flow readings on Combomap machine (Volcano Therapeutics, CA).
- Adenosine - stress agent during catheterization, 140 ug/Kg/min
| Study group | Role | What they receive |
|---|---|---|
| Cardiac PET, Coronary catheterization | Cardiac PET scan:
1. Injection of N-13 Ammonia radionuclide. 2 doses of 10 milliCuries and 20 milliCuries each.
2. Injection of Lexiscan.
Coronary catheterization:
1. Pressure and flow readings using Combowire
2. Injection of Adenosine. Receives: Procedure: Cardiac PET, Coronary catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of relative contributions of large artery disease and microvascular disease
Correlation Coronary Flow Reserve (CFR) from Positron Emission Tomography (PET)imaging with diagnostic parameters, Pressure Drop Coefficient (CDP) and Lesion Flow Coefficient (LFC).
Measured: 2 years
Secondary outcomes (1)
Quantification of relative contributions of large artery disease and microvascular disease
Correlation of CDP and LFC with invasively measured Fractional Flow Reserve (FFR) values.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startAug 2010
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupak K. Banerjee, University of Cincinnati
- Investigators
- Rupak K Banerjee, PhD, Principal investigator, University of Cincinnati , CVAMCMohamed Effat, MD, Principal investigator, Univesity of Cincinnati, University HospitalImran Arif, MD, Principal investigator, University of Cincinnati and University HospitalHanan Kerr, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719016
- Sponsor's protocol ID
- 10-05-05-02
- Status last verified
- Sep 2026
- First submitted
- 29 Oct 2012
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Banerjee RK, Ramadurai S, Manegaonkar SM, Rao MB, Rakkimuthu S, Effat MA. Comparison Between 5- and 1-Year Outcomes Using Cutoff Values of Pressure Drop Coefficient and Fractional Flow Reserve for Diagnosing Coronary Artery Diseases. Front Physiol. 2021 Jul 14;12:689517. doi: 10.3389/fphys.2021.689517. eCollection 2021.
PubMed 34335296
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics
- ClinicalTrials.gov ID
- NCT01719016
- Acronym / sponsor ID
- 10-05-05-02
- Conditions
- Coronary Artery Disease
- Keywords
- Reversible ischemia, microvascular dysfunction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 1 Nov 2012 (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.
Diagnosis of relative contributions of large artery blockages and microvascular blockages is very much needed in the treatment of coronary artery disease. In order to achieve this, two novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with pressure and flow readings, are being investigated.
Detailed description
Diagnosis of relative contributions of large artery blockages and microvascular blockages is very much needed in the treatment of coronary artery disease. In order to achieve this, two novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with pressure and flow readings, are being investigated. The diagnostic parameters will be correlated with Coronary Flow Reserve (CFR)values obtained using Positron Emission Tomography (PET) imaging. They will also be correlated with Fractional Flow Reserve (FFR).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac PET, Coronary catheterization | – | Procedure: Cardiac PET, Coronary catheterizationCardiac PET scan: 1. Injection of N-13 Ammonia radionuclide. 2 doses of 10 milliCuries and 20 milliCuries each. 2. Injection of Lexiscan. Coronary catheterization: 1. Pressure and flow readings using Combowire 2. Injection of Adenosine. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chest pain and suspected ischemia that needs to be assessed by a stress test
Key inclusion criteria (8 listed)
- 18 years of age or above
- Patients referred to a stress test by a Cardiologist
- Acute Chest pain, as per patient input.
- Risk Assessment with prior test results and/or previous history of known chronic stable CAD.
- Borderline or discordant stress testing where obstructive CAD remains a concern.
Key exclusion criteria (6 listed)
- Left ventricular ejection fraction less the 25% determined by gated SPECT imaging
- Non-dialysis dependent chronic kidney disease with baseline serum creatinine greater than 2.5 gm/dL.
- History of type II heparin-induced thrombocytopenia.
- Significant co-morbid condition that is medically unstable and would make coronary angiography prohibitive or contraindicated.
- Pregnant women.
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 |
|---|---|---|
| Cardiac PET, Coronary catheterizationAlso: Volcano therapeutics, Combomap machine, Adenosine, LexiscanPatients would under go a Cardiac rest and stress PET scan and include the following drug administration: 1. N-13 Ammonia radionuclide - Two doses, 10 mCi for rest, 20 mCi for stress 2. Lexiscan - stress agent for PET scan Patients would also undergo Coronary catheterization including the following drug administration and device usage: 1. Combowire to obtain pressure and flow readings on Combomap machine (Volcano Therapeutics, CA). 2. Adenosine - stress agent during catheterization, 140 ug/Kg/min | Procedure or surgery | Cardiac PET, Coronary catheterization |
Primary outcome
Quantification of relative contributions of large artery disease and microvascular disease
Time frame: 2 years
Correlation Coronary Flow Reserve (CFR) from Positron Emission Tomography (PET)imaging with diagnostic parameters, Pressure Drop Coefficient (CDP) and Lesion Flow Coefficient (LFC).
1 secondary outcome
Quantification of relative contributions of large artery disease and microvascular disease
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Derived from this study: PubMed 34335296Banerjee RK, Ramadurai S, Manegaonkar SM, Rao MB, Rakkimuthu S, Effat MA. Comparison Between 5- and 1-Year Outcomes Using Cutoff Values of Pressure Drop Coefficient and Fractional Flow Reserve for Diagnosing Coronary Artery Diseases. Front Physiol. 2021 Jul 14;12:689517. doi: 10.3389/fphys.2021.689517. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
Rupak K Banerjee, PhD principal investigator
University of Cincinnati , CVAMC
Mohamed Effat, MD principal investigator
Univesity of Cincinnati, University Hospital
Imran Arif, MD principal investigator
University of Cincinnati and University Hospital
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 Coronary Artery Disease, run by University of Cincinnati 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 8 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Quantification of relative contributions of large artery disease and microvascular disease (time frame: 2 years). 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 NCT01719016, 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 4 Sep 2026.