An observational study in Coronary Microvascular Dysfunction, Coronary Microvascular Disease and Non-Obstructive Coronary Atherosclerosis, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Istanbul University · Observational
Coronary Microvascular Dysfunction has been consistently shown to play a considerable role in pathophysiology of Ischaemia with non-obstructed coronary arteries (INOCA). While the both diagnoses are individually related to remarkably worse outcome, there is no available method to simultaneously determine INOCA-CMD endotypes in vessel level, during the invasive diagnosis.
The investigators hereby hypothesize that, combined intracoronary electrocardiogram (IC-ECG) (considering the high sensitivity and specificity of IC-ECG for studied vessel-territory) and intracoronary doppler can simultaneously and successfully identify vessel specific coronary microvascular dysfunction and resulting ischemia, which may potentially enable immediate diagnosis and endotyping of CMD-INOCA subgroups during the invasive assessment of first ANOCA episode, obviating the need for further ischemia-studies such es SPECT, which have considerably higher costs and lower sensitivity.
Major coronary arteries of patients aged between 18 - 75 without obstructing coronary artery disease who have previously documented ischemia with non-obstructed coronary arteries (INOCA) via coronary angiogram and myocardial perfusion scan will be evaluated simultaneously with IC-ECG and intracoronary Doppler during rest and under adenosine induced hyperaemia.
Performance of the combined system to identify Coronary Microvascular Dysfunction with structural and functional subgroups as defined by abnormal Coronary Flow Reserve (CFR) and Hyperemic Microvascular Resistance (HMR) and Ischemia in downstream territories of same vessel area (as defined by perfusion scan) is intended to be determined.
The investigators also intend to interrogate the possible relationship between dynamic changes in IC-ECG parameters and invasively obtained intracoronary hemodynamic data.
Background and Rationale of Study
Coronary Microvascular Dysfunction has been consistently shown to play a considerable role in pathophysiology of Ischaemia with non-obstructed coronary arteries (INOCA). While the both diagnoses are individually related to remarkably worse outcome, there is no available method to simultaneously determine INOCA-CMD endotypes in vessel level, during the invasive diagnosis.
Hypothesis
The investigators hereby hypothesize that, combined intracoronary electrocardiogram (IC-ECG) (considering its high sensitivity for ischemia and specificity for studied vessel-territory) and intracoronary doppler can simultaneously and successfully identify vessel specific coronary microvascular dysfunction and resulting ischemia, which may potentially enable immediate diagnosis and endotyping of CMD-INOCA subgroups during the invasive assessment of first ANOCA episode, obviating the need for further ischemia-studies such as SPECT, which have considerably higher costs and lower sensitivity and requires more hospital visits.
Study Method
Major coronary arteries of patients aged between 18 - 75 without obstructing coronary artery disease who have previously documented ischaemia with non-obstructed coronary arteries (INOCA) via coronary angiogram and myocardial perfusion scan will be evaluated simultaneously with IC-ECG and intracoronary Doppler during rest and under adenosine induced hyperaemia after obtaining informed consent. Flow (APVr, APVh) data will be collected via intracoronary doppler during rest and adenosine induced hyperaemia in concordance with guidelines and Coronary Flow Reserve will be determined. Microvascular resistances (HMR, BMR) will be calculated with distal pressures and flow data.
Simultaneous with intracoronary Doppler, IC-ECG records will be obtained during rest and hyperaemia. Paper records will be digitized offline in MATLAB environment. Delta ST, Delta ST integral, Delta T, Delta T integral will be measured and calculated and quantified as continuous values.
All participants will be go through careful medical evaluation and presence of exclusion criteria will be assessed.
At the end of the data collection period, all available major coronary arteries are expected to have:
Structural/Functional Microvascular Status: (CFR and HMR)
-Definition of Coronary Microvascular Dysfunction and Subgroups: CMD is defined as CFR \< 2.5. Those with concomitant HMR > 1.9 will be further labeled as structural CMD whereas vessels with CFR \<2.5 and HMR \<1.9 will be labeled as functional CMD.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 35 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
18 - 75 years old patients with previously documented ischemia with non-obstructed coronary arteries and positive ischemia test (myocardial perfusion scan or slow-flow) to be enrolled. Patients meeting at least one exclusion criteria won't be enrolled.
Exclusion Criteria:
Hyperemic Microvascular Resistance (HMR)
the ratio of mean distal coronary pressure to average flow velocity
Time frame: Intraprocedural during coronary angiography
Coronary Flow Reserve (CFR)
the ratio between coronary blood flow at maximal hyperemia and at baseline condition
Time frame: Intraprocedural during coronary angiography
Delta ST
absolute shift of ST segment in IC-ECG record (at J point)
Time frame: Intraprocedural during coronary angiography
Delta ST Integral
absolute change in area between ST segment and isoelectric line
Time frame: Intraprocedural during coronary angiography
Resting Average Peak Velocity
Time frame: Intraprocedural during coronary angiography
Hyperemic Average Peak Velocity
Time frame: Intraprocedural during coronary angiography
Basal Microvascular Resistance (BMR)
Time frame: Intraprocedural during coronary angiography
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Istanbul University