- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03393871
Myocardial Mass Determination by FFRct and Absolute Coronary Blood Flow (MyoMass)
Myocardial Mass Determination of the Different Coronary Territories by FFRct and Invasive Measurement of Absolute Coronary Blood Flow. A Clinical Registry
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although knowledge about the myocardial mass (in grams) of the different territories belonging to the major coronary arteries, is of clinical importance to estimate risk of coronary interventions (PCI, CABG) and to determine area of necrosis after myocardial infarction, no invasive methodology has been available so far for reliable assessment of mass.
Especially in the setting of percutaneous coronary intervention (PCI), it would be valuable to have information about the absolute and relative myocardial mass distal to the location where the intervention is planned. Such information is valuable for risk estimation and can also be helpful in multivessel disease to determine the most adequate way of revascularization.
Both MRI and CT scanning have claimed to be able to estimate myocardial mass non-invasively, but by the lack of any gold standard, none of these methods could be validated in vivo so far.
A relatively new development in CT technology is the calculation of fractional flow reserve (FFR) by CT scanning, according to a sophisticated algorithm developed by Heartflow Inc. One of the baseline assumptions in that algorithm is that myocardial mass is proportional to resting blood flow, which seems a plausible assumption from a rational physiological point of view.
More recently, invasive calculation of absolute blood flow has become possible as well as resistance measurement of the (microcirculation of the) myocardium.
Using that invasive technology (explained in the appendix to this protocol), it can be assumed that measuring absolute maximum blood flow in a coronary artery as well as fractional flow reserve for different territories or for different spots within one major coronary artery, provides a basis for relative mass calculation. The background for performing the present study is to compare these mass calculations by CT scanning and by invasive measurements, thereby corroborating both methods.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Brabant
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Eindhoven, Brabant, Netherlands, 5623EJ
- Catharina Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Sixty patients will be included who are scheduled
- Either for multivessel FFR/PCI fulfilling the following criteria and not meeting any of the exclusion criteria (prospective group)
- Or patients in whom both coronary CT scanning and invasive exams have been performed already for clinical reasons and of whom "complete data" are available already (retrospective group)
Description
Inclusion Criteria:
- Presence of multivessel coronary disease with an indication for multivessel FFR and/or PCI or patients with single vessel disease scheduled for FFR/PCI of that single coronary artery
- Availability of a coronary CT scan performed prior to the scheduled invasive investigation. The time difference between the CT scan and the invasive exam should be less than 3 months.
- Focal lesions only
- Normal left ventricular function
- Age < 75 years
- Note: previous uncomplicated PCI in any of the coronary arteries is permitted
Exclusion Criteria:
- Inability to give informed consent
- Diffuse coronary disease
- Tortuous or calcified arteries interfering with reliable invasive FFR assessment
- Previous myocardial infarction or ejection fraction less than 60% by echocardiography or ventriculography or less than 50% by nuclear methods
- Atrial fibrillation interfering with high quality coronary CT scanning
- Contra-indications for CT scanning
- Left main stenosis
- Age > 75 years
- Pregnancy or desired pregnancy in the future
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Mass and flow
Time Frame: 3 months
|
To compare relative myocardial mass distribution (i.e.
mass of the respective territories of LAD, LCX and RCA) by CT scanning to normalized hyperemic blood flow in the three major myocardial territories as assessed by absolute flow measurements and FFR in patients with an indication for multivessel FFR measurement.
|
3 months
|
Comparison of Mass and flow in the LAD
Time Frame: 3 months
|
To compare relative myocardial mass belonging to a proximal or a mid segment of one of the major coronary arteries measured by CT scanning to invasive absolute flow and FFR measurement in that particular proximal or mid coronary artery in patients undergoing single or multivessel PCI.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nico HJ Pijls, MD, PhD, Catharina Ziekenhuis Eindhoven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MyoMass
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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