Coronary Artery DiseaseNCT02286401
Functional Assessment of Coronary Artery Disease by CTA Flow Encoding
An observational study of Coronary Artery Disease, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this pilot study proposal is to test the ability of Transluminal Flow Encoding (TAFE) to evaluate vessel specific ischemia in patients with a clinical indication for invasive coronary angiography (ICA) with fractional flow reserve (FFR) measurements for suspected coronary disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 31 Dec 2016
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptoms suspicious for obstructive coronary artery disease who will undergo cardiac catheterization.
Who may be able to join
- Inclusion Criteria A. Male or female patients, age 40 years and older. Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CT.
- Referral for invasive coronary angiography for a suspicion of coronary artery disease with possible percutaneous intervention planned.
- Able to understand and willing to sign the Informed Consent Form.
Who cannot join
- Patients with a known history of coronary artery bypass surgery. B. Current or previous ST elevation myocardial infarction (MI), prior MI (confirmed by persistent pathologic Q waves on ECG, clinical reports of CPK-MB or Troponin > three times the upper limit of normal or a fixed perfusion defect on nuclear imaging) C. Current evidence of acute myocardial ischemia, unstable angina, or cardiovascular instability including troponin > than the limit of detection (≥0.06 ng/ml), new ST depression > 1 mm, hypotension with a systolic pressure <90 mm Hg.
- Known allergy to iodinated contrast media
- Known or suspected intolerance or contraindication to beta-blockers including:
- Known allergy to beta-blockers
- History of moderate to severe bronchospastic lung disease (including moderate to severe asthma) F. Known allergy to regadenoson or aminophylline. G. Any patient not deemed medically stable by a physician. F. Known or suspected severe symptomatic aortic stenosis. G. Severe hypertrophic obstructive cardiomyopathy. H. Evidence of severe symptomatic heart failure (NYHA Class III or IV) at the time of the scan.
- Inability to lie flat. J. Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block) K. Elevated serum creatinine (> 1.5mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula) L. History of contrast-induced nephropathy M. Severe pulmonary disease or other disorder that does not allow patient to hold breath for 10 seconds or more.
- History of organ transplantation O. Acute myocarditis or pericarditis. P. Recent history of illicit drug use (past 3 months) Q. Recent use of dipyridamole containing medications. R. Current pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study proposal is to test the ability of Transluminal Flow Encoding (TAFE) to evaluate vessel specific ischemia in patients with a clinical indication for invasive coronary angiography (ICA) with fractional flow reserve (FFR) measurements for suspected coronary disease.
Read the detailed description
The purpose of this pilot study is to test the ability of Transluminal Flow Encoding (TAFE) to evaluate vessel specific ischemia in patients with a clinical indication for invasive coronary angiography (ICA) with fractional flow reserve (FFR) measurements for suspected coronary disease. TAFE is a novel method that derives coronary blood flow from easily obtainable non-invasive coronary CT angiograms.
Participants will undergo a rest coronary CTA, a regadenoson stress CT, and a clinically indicated invasive coronary angiogram. The study aims to determine the accuracy of TAFE compared to invasive fractional flow reserve.
We hypothesize that TAFE-derived coronary blood flow, coronary flow reserve, and myocardial CT perfusion imaging can accurately diagnose an abnormal FFR (<0.80) measured in vessels in patients undergoing invasive coronary angiography.
- Conditions
- Coronary Artery Disease
- Keywords
- myocardial perfusion, coronary atherosclerosis, coronary blood flow, fractional flow reserve, coronary flow reserve
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Coronary Computed Tomography Angiography (CTA), myocardial CT perfusion and TAFE to predict invasive FFR
We will test the diagnostic accuracy of Coronary CTA, myocardial CT perfusion, and transluminal attenuation flow encoding (TAFE) to predict fractional flow reserve (FFR). Coronary CTA and myocardial CT perfusion results will be dichotomous, either normal or abnormal. Coronary CTA will be defined as abnormal when there is a > or = 50% diameter stenosis in a coronary vessel. Myocardial CT perfusion will be defined as abnormal when there is a visually determined myocardial perfusion deficit. TAFE will be a continuous variable in units of ml/min.
The reference standard will be invasive fractional flow reserve (FFR). FFR will be defined as abnormal when it is less than 0.80.
Measured: 2 years
Secondary outcomes (1)
Diagnostic Accuracy of TAFE-derived coronary blood flow to predict invasive FFR
We will test the diagnostic accuracy of TAFE derived coronary blood flow in ml/min to predict and abnormal FFR (<0.80)
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 posted7 Nov 2014 (estimated)
- Study startOct 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Why it stopped: Recruitment lagged behind goal;exhaustion of funding.
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 Johns Hopkins 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armin R Zadeh, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286401
- Sponsor's protocol ID
- NA_00091805
- Status last verified
- Dec 2017
- First submitted
- 3 Nov 2014
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assessment of Coronary Artery Disease by CTA Flow Encoding
- ClinicalTrials.gov ID
- NCT02286401
- Acronym / sponsor ID
- NA_00091805
- Conditions
- Coronary Artery Disease
- Keywords
- myocardial perfusion, coronary atherosclerosis, coronary blood flow, fractional flow reserve, coronary flow reserve
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment lagged behind goal;exhaustion of funding.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 7 Nov 2014 (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.
The purpose of this pilot study proposal is to test the ability of Transluminal Flow Encoding (TAFE) to evaluate vessel specific ischemia in patients with a clinical indication for invasive coronary angiography (ICA) with fractional flow reserve (FFR) measurements for suspected coronary disease.
Detailed description
The purpose of this pilot study is to test the ability of Transluminal Flow Encoding (TAFE) to evaluate vessel specific ischemia in patients with a clinical indication for invasive coronary angiography (ICA) with fractional flow reserve (FFR) measurements for suspected coronary disease. TAFE is a novel method that derives coronary blood flow from easily obtainable non-invasive coronary CT angiograms.
Participants will undergo a rest coronary CTA, a regadenoson stress CT, and a clinically indicated invasive coronary angiogram. The study aims to determine the accuracy of TAFE compared to invasive fractional flow reserve.
We hypothesize that TAFE-derived coronary blood flow, coronary flow reserve, and myocardial CT perfusion imaging can accurately diagnose an abnormal FFR (<0.80) measured in vessels in patients undergoing invasive coronary angiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptoms suspicious for obstructive coronary artery disease who will undergo cardiac catheterization.
Key inclusion criteria (3 listed)
- Inclusion Criteria A. Male or female patients, age 40 years and older. Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CT.
- Referral for invasive coronary angiography for a suspicion of coronary artery disease with possible percutaneous intervention planned.
- Able to understand and willing to sign the Informed Consent Form.
Key exclusion criteria (7 listed)
- Patients with a known history of coronary artery bypass surgery. B. Current or previous ST elevation myocardial infarction (MI), prior MI (confirmed by persistent pathologic Q waves on ECG, clinical reports of CPK-MB or Troponin > three times the upper limit of normal or a fixed perfusion defect on nuclear imaging) C. Current evidence of acute myocardial ischemia, unstable angina, or cardiovascular instability including troponin > than the limit of detection (≥0.06 ng/ml), new ST depression > 1 mm, hypotension with a systolic pressure <90 mm Hg.
- Known allergy to iodinated contrast media
- Known or suspected intolerance or contraindication to beta-blockers including:
- Known allergy to beta-blockers
- History of moderate to severe bronchospastic lung disease (including moderate to severe asthma) F. Known allergy to regadenoson or aminophylline. G. Any patient not deemed medically stable by a physician. F. Known or suspected severe symptomatic aortic stenosis. G. Severe hypertrophic obstructive cardiomyopathy. H. Evidence of severe symptomatic heart failure (NYHA Class III or IV) at the time of the scan.
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 of Coronary Computed Tomography Angiography (CTA), myocardial CT perfusion and TAFE to predict invasive FFR
Time frame: 2 years
We will test the diagnostic accuracy of Coronary CTA, myocardial CT perfusion, and transluminal attenuation flow encoding (TAFE) to predict fractional flow reserve (FFR). Coronary CTA and myocardial CT perfusion results will be dichotomous, either normal or abnormal. Coronary CTA will be defined as abnormal when there is a > or = 50% diameter stenosis in a coronary vessel. Myocardial CT perfusion will be defined as abnormal when there is a visually determined myocardial perfusion deficit. TAFE will be a continuous variable in units of ml/min. The reference standard will be invasive fractional flow reserve (FFR). FFR will be defined as abnormal when it is less than 0.80.
1 secondary outcome
Diagnostic Accuracy of TAFE-derived coronary blood flow to predict invasive FFR
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Recruitment lagged behind goal;exhaustion of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
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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.
Armin R Zadeh, MD principal investigator
Johns Hopkins University
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 Johns Hopkins University 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 7 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 6 Dec 2017. 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 was stopped early (reason given: Recruitment lagged behind goal;exhaustion of funding.). 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?
Diagnostic Accuracy of Coronary Computed Tomography Angiography (CTA), myocardial CT perfusion and TAFE to predict invasive FFR (time frame: 2 years). 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 6 Dec 2017.