Coronary Artery Stenosis of Unclear Hemodynamic RelevanceNCT03101696
Determination of Coronarphysiological Parameters With the Method of Thermodillution
An observational study of Coronary Artery Stenosis of Unclear Hemodynamic Relevance, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
The gold standard to induce coronary hyperemia for measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) is adenosine, but it exerts several side effects due to its unspecific action on adenosine receptors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Stenosis of Unclear Hemodynamic Relevance
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 5 Feb 2017to 28 Feb 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with indication for FFR measurement due to a coronary artery stenosis of unclear hemodynamic relevance
Who may be able to join
- Coronary angiography with indication of FFR measurement
- angiography without pathological results explaining the patients' symptoms
- intermediate stenosis (50-70%)
Who cannot join
- <18 years
- Hypersensitivity towards regadenoson
- hemodynamic instability
- severe hypotension
- acute myocardial ischemia
- AV block II-III
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
About this study
The gold standard to induce coronary hyperemia for measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) is adenosine, but it exerts several side effects due to its unspecific action on adenosine receptors. The specific A2a-receptor agonist, regadenoson, has been shown to dilate coronary arteries and enables FFR measurements. The aim of the study was to evaluate whether simultaneous measurement of FFR, CFR and IMR is feasible, safe and effective within regadenoson-induced hyperemia.
Read the detailed description
Fractional flow reserve (FFR), coronary flow reserve (CFR) and the index of microcirculatory resistance (IMR) provide significant information on the conductance of coronary macro- and microcirculation.
FFR-based functional assessment of coronary artery disease has proven to be superior to purely morphologic assessment and thereby guides therapy decision. IMR is a pressure-temperature derived parameter for quantifying microcirculatory resistance, which has been proven to be relatively independent of epicardial stenosis severity when taking collateral flow into account. IMR is increased in patients with acute myocardial infarction and microvascular obstruction (MVO) as assessed by contrast-enhanced CMR and predicts left ventricular function and enddiastolic volumes at 6 month independently of initial infarct size.
Most interestingly, even in the absence of obstructive coronary artery disease, IMR is elevated in more than 20% of patients presenting with chest pain. The clinical meaning for this finding has to be elucidated.
FFR, CFR and IMR can only be measured under conditions of minimal coronary resistance with the need for coronary hyperemia. The current "gold standard" to induce hyperemia in the assessment of coronary conductance is adenosine. However, adenosine is known to cause side effects (bronchospasm and disturbances in atrioventricular conduction) due to its unselective action on all adenosine receptors. Besides that, adenosine requires a body weight adapted dosing and continuous infusion. However, alternative routes like intracoronary injection show good correlation compared with the intravenous route and side effects can be reduced. In contrast, regadenoson, a specific A2A receptor agonist, exhibits negligible side effects. It can be administered intravenously as a non-body weight adapted bolus via peripheral vein without the need for transfemoral delivery. Thus, patients with a transradial access for cardiac catheterization might benefit the most from inducing hypermedia via peripheral vein. It has already been shown that regadenoson increases coronary blood flow yielding comparable values for FFR and indexes of perfusion in SPECT. However, the duration and stability of regadenoson-induced hyperemia might be insufficient for a simultaneous measurement of FFR, CFR and IMR, which has not been tested so far.
The aim of the present study is to evaluate whether simultaneous measurement of the parameters FFR, CFR and IMR under regadenoson-induced hyperemia is feasible, safe and effective in patients with stable coronary artery disease undergoing a transradial procedure
- Keywords
- coronary angiography, coronary conductance, hyperemia, regadenoson, fractional flow reserve, coronary flow reserve, index of microcirculatory resistance
- Medical subject headings
- Hyperemia
What is being measured
The primary outcome is the main question the study is designed to answer.
fractional flow reserve (FFR)
Description: the proximal aortic (Pa) and distal arterial pressure (Pd) are recorded and RadiAnalyzer Xpress™ control unit automatically calculates FFR as Pd/Pa
Measured: Baseline
Secondary outcomes (2)
coronary flow reserve
The RadiAnalyzer Xpress™ calculates CFR as Tmnr/Tmnh
Measured: Baseline
index of microcirculatory resistance
Using the derived Pd and transit mean times under hyperemia (Tmnh), it will be calculated apparent IMR as Pd×Tmnh. All IMR values are also corrected by Yong's formula (IMRcorr=Pa×Tmnh×([1.35×Pd/Pa]-0.32) to adjust for the influence of collateral flow.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start5 Feb 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Stenosis of Unclear Hemodynamic RelevanceStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Malte Kelm, MD, Study chair, Division of Cardiology, Pulmonary Disease and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101696
- Sponsor's protocol ID
- 16-024
- Status last verified
- Mar 2019
- First submitted
- 30 Mar 2017
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Coronarphysiological Parameters With the Method of Thermodillution
- ClinicalTrials.gov ID
- NCT03101696
- Acronym / sponsor ID
- 16-024
- Keywords
- coronary angiography, coronary conductance, hyperemia, regadenoson, fractional flow reserve, coronary flow reserve, index of microcirculatory resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 5 Feb 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 5 Apr 2017 (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.
The gold standard to induce coronary hyperemia for measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) is adenosine, but it exerts several side effects due to its unspecific action on adenosine receptors. The specific A2a-receptor agonist, regadenoson, has been shown to dilate coronary arteries and enables FFR measurements. The aim of the study was to evaluate whether simultaneous measurement of FFR, CFR and IMR is feasible, safe and effective within regadenoson-induced hyperemia.
Detailed description
Fractional flow reserve (FFR), coronary flow reserve (CFR) and the index of microcirculatory resistance (IMR) provide significant information on the conductance of coronary macro- and microcirculation.
FFR-based functional assessment of coronary artery disease has proven to be superior to purely morphologic assessment and thereby guides therapy decision. IMR is a pressure-temperature derived parameter for quantifying microcirculatory resistance, which has been proven to be relatively independent of epicardial stenosis severity when taking collateral flow into account. IMR is increased in patients with acute myocardial infarction and microvascular obstruction (MVO) as assessed by contrast-enhanced CMR and predicts left ventricular function and enddiastolic volumes at 6 month independently of initial infarct size.
Most interestingly, even in the absence of obstructive coronary artery disease, IMR is elevated in more than 20% of patients presenting with chest pain. The clinical meaning for this finding has to be elucidated.
FFR, CFR and IMR can only be measured under conditions of minimal coronary resistance with the need for coronary hyperemia. The current "gold standard" to induce hyperemia in the assessment of coronary conductance is adenosine. However, adenosine is known to cause side effects (bronchospasm and disturbances in atrioventricular conduction) due to its unselective action on all adenosine receptors. Besides that, adenosine requires a body weight adapted dosing and continuous infusion. However, alternative routes like intracoronary injection show good correlation compared with the intravenous route and side effects can be reduced. In contrast, regadenoson, a specific A2A receptor agonist, exhibits negligible side effects. It can be administered intravenously as a non-body weight adapted bolus via peripheral vein without the need for transfemoral delivery. Thus, patients with a transradial access for cardiac catheterization might benefit the most from inducing hypermedia via peripheral vein. It has already been shown that regadenoson increases coronary blood flow yielding comparable values for FFR and indexes of perfusion in SPECT. However, the duration and stability of regadenoson-induced hyperemia might be insufficient for a simultaneous measurement of FFR, CFR and IMR, which has not been tested so far.
The aim of the present study is to evaluate whether simultaneous measurement of the parameters FFR, CFR and IMR under regadenoson-induced hyperemia is feasible, safe and effective in patients with stable coronary artery disease undergoing a transradial procedure
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with indication for FFR measurement due to a coronary artery stenosis of unclear hemodynamic relevance
Key inclusion criteria (3 listed)
- Coronary angiography with indication of FFR measurement
- angiography without pathological results explaining the patients' symptoms
- intermediate stenosis (50-70%)
Key exclusion criteria (6 listed)
- <18 years
- Hypersensitivity towards regadenoson
- hemodynamic instability
- severe hypotension
- acute myocardial ischemia
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
fractional flow reserve (FFR)
Time frame: Baseline
Description: the proximal aortic (Pa) and distal arterial pressure (Pd) are recorded and RadiAnalyzer Xpress™ control unit automatically calculates FFR as Pd/Pa
2 secondary outcomes
coronary flow reserve
Time frame: Baseline
index of microcirculatory resistance
Time frame: Baseline
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 26 Mar 2019.
- Individual participant dataSharing planned: Yes
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.
Malte Kelm, MD study chair
Division of Cardiology, Pulmonary Disease and Vascular Medicine
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 Stenosis of Unclear Hemodynamic Relevance, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 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: finished, as of the sponsor's last update on 26 Mar 2019. 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 Germany. 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?
fractional flow reserve (FFR) (time frame: Baseline). 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 26 Mar 2019.