Coronary Artery DiseaseMASESNCT00760630
Measurements to Assess Severity of Epicardial Stenoses
An observational study of Coronary Artery Disease, run by University of Cincinnati at 2 sites in United States.
Trial summary
Newly developed diagnostic parameters have potential to differentiate between epicardial disease and microvascular dysfunction with the help of anatomical details and physiological endpoints and can be used in present clinical settings. 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?
- FFR/CFR and IVUS
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to 24 Feb 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 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
- Abnormal Myocardial stress perfusion (SPECT) LV EF > 25%
- 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.
Show all 9Show fewer
- 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
- Serum Creatinine > 2.5 gm/dL
- Type II HIT
- Left ventricular ejection fraction less the 25% determined by gated SPECT imaging ( - LV < or + to 25%)
- 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
2 sites in 1 country.
United States2 sites
University Hospital
Cincinnati, Ohio, 45219
Department of Veterans Affairs
Cincinnati, Ohio, 45220
About this study
Official title: Simultaneous Measurements Of Pressure Gradient, Blood Flow and Percentage Area Stenosis Of Coronary Epicardial Lesions To Assess Severity Of Epicardial Stenosis And Myocardial Infarction
Newly developed diagnostic parameters have potential to differentiate between epicardial disease and microvascular dysfunction with the help of anatomical details and physiological endpoints and can be used in present clinical settings.
Read the detailed description
The pressure drop coefficient (CDP) is a functional index based on hyperemic dp and u measurements. The lesion flow coefficient (LFC) combines the functional index CDP with an atomic measure (percentage area stenosis) as a single parameter.
- Conditions
- Coronary Artery Disease
- Being tested
- FFR/CFR and IVUS
- Keywords
- abnormal stress test, fractional flow reserve, pressure drop coefficient, lesion flow coefficient
- 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.
FFR/CFR and IVUSDevice
Also called Volcano FFR and IVUS catheters will be used
All patients with clinical indication for cardiac cath will have FFR and IVUS
| Study group | Role | What they receive |
|---|---|---|
| CDP LFC | all patients will have this calculation based upon diagnostic parameters with IVUS and FFR and/or CFR Receives: Device: FFR/CFR and IVUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
to detect ischemic heart disease in patients with abnormal stress tests using MPI with SPECT and to determine the presence of significant epicardial stenosis using coronary angiography with simultaneous physiological pressure and flow measurements
Measured: Upon Diagnostic Angiogram and Flow Wire
Secondary outcomes (1)
To compare novel measurements, Pressure Drop Coefficient (CDP) & Lesion Flow Coefficient (LFC), against measured current parameters called Fractional flow reserve (FFR) & Coronary flow reserve (CFR).
Measured: Upon Diagnostic Angiogram and Flow Wire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startDec 2009
- Primary completion24 Feb 2012
- Study completion24 Feb 2012
Why it stopped: IRB Approval expired on 05/28/09 as it was pilot study. A new study was later initiated once VA Merit Review Grant (I01CX000342-01) was received. Thus a new IRB (10-05-05-02) and clinicaltrials.gov (NCT01719016) were initiated in place of this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Rupak K. Banerjee, University of Cincinnati
- Investigators
- Mohamed Effat, MD, Principal investigator, University of CincinnatiKranthi K Kolli, MS, Principal investigator, University of CincinnatiMassoud Leesar, MD, Principal investigator, University of CincinnatiRupak Banerjee, PhD, Principal investigator, University of CincinnatiTarek Helmy, MD, Principal investigator, University of CincinnatiSrikara Pellukhana, BS, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760630
- Sponsor's protocol ID
- UCIRB08031108
- Acronym
- MASES
- Status last verified
- Jun 2026
- First submitted
- 24 Sep 2008
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Measurements Of Pressure Gradient, Blood Flow and Percentage Area Stenosis Of Coronary Epicardial Lesions To Assess Severity Of Epicardial Stenosis And Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00760630
- Acronym / sponsor ID
- MASES / UCIRB08031108
- Conditions
- Coronary Artery Disease
- Keywords
- abnormal stress test, fractional flow reserve, pressure drop coefficient, lesion flow coefficient
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: IRB Approval expired on 05/28/09 as it was pilot study. A new study was later initiated once VA Merit Review Grant (I01CX000342-01) was received. Thus a new IRB (10-05-05-02) and clinicaltrials.gov (NCT01719016) were initiated in place of this study.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Dec 2009 (actual)
- Primary completion
- 24 Feb 2012 (actual)
- Study completion
- 24 Feb 2012 (actual)
- First posted
- 26 Sep 2008 (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.
Newly developed diagnostic parameters have potential to differentiate between epicardial disease and microvascular dysfunction with the help of anatomical details and physiological endpoints and can be used in present clinical settings.
Detailed description
The pressure drop coefficient (CDP) is a functional index based on hyperemic dp and u measurements. The lesion flow coefficient (LFC) combines the functional index CDP with an atomic measure (percentage area stenosis) as a single parameter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDP LFC | – | Device: FFR/CFR and IVUSall patients will have this calculation based upon diagnostic parameters with IVUS and FFR and/or CFR |
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 (9 listed)
- Abnormal Myocardial stress perfusion (SPECT) LV EF > 25%
- 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.
Key exclusion criteria (8 listed)
- Serum Creatinine > 2.5 gm/dL
- Type II HIT
- Left ventricular ejection fraction less the 25% determined by gated SPECT imaging ( - LV < or + to 25%)
- Non-dialysis dependent chronic kidney disease with baseline serum creatinine greater than 2.5 gm/dL.
- History of type II heparin-induced thrombocytopenia.
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 |
|---|---|---|
| FFR/CFR and IVUSAlso: Volcano FFR and IVUS catheters will be usedAll patients with clinical indication for cardiac cath will have FFR and IVUS | Device | CDP LFC |
Primary outcome
to detect ischemic heart disease in patients with abnormal stress tests using MPI with SPECT and to determine the presence of significant epicardial stenosis using coronary angiography with simultaneous physiological pressure and flow measurements
Time frame: Upon Diagnostic Angiogram and Flow Wire
1 secondary outcome
To compare novel measurements, Pressure Drop Coefficient (CDP) & Lesion Flow Coefficient (LFC), against measured current parameters called Fractional flow reserve (FFR) & Coronary flow reserve (CFR).
Time frame: Upon Diagnostic Angiogram and Flow Wire
Results and safety
The study was stopped early (reason given: IRB Approval expired on 05/28/09 as it was pilot study. A new study was later initiated once VA Merit Review Grant (I01CX000342-01) was received. Thus a new IRB (10-05-05-02) and clinicaltrials.gov (NCT01719016) were initiated in place of this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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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.
Mohamed Effat, MD principal investigator
University of Cincinnati
Kranthi K Kolli, MS principal investigator
University of Cincinnati
Massoud Leesar, MD principal investigator
University of Cincinnati
2 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, run by University of Cincinnati at 2 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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: IRB Approval expired on 05/28/09 as it was pilot study. A new study was later initiated once VA Merit Review Grant (I01CX000342-01) was received. Thus a new IRB (10-05-05-02) and clinicaltrials.gov (NCT01719016) were initiated in place of this study.). Results are not available in the source record.
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?
to detect ischemic heart disease in patients with abnormal stress tests using MPI with SPECT and to determine the presence of significant epicardial stenosis using coronary angiography with simultaneous physiological pressure and flow measurements (time frame: Upon Diagnostic Angiogram and Flow Wire). 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 10 Jun 2026.