An interventional study of Swan-Ganz catheter placed in the coronary sinus - deflated and Swan-Ganz catheter placed in the coronary sinus - inflated in Microvascular Coronary Artery Disease, sponsored by Johannes Gutenberg University Mainz. Completed at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Johannes Gutenberg University Mainz · Not applicable, Interventional, and Basic science
MACCHUS is a randomized, single-center, controlled, cross-over interventional study in which coronary artery resistances will be measured at baseline and during temporary occlusion of the coronary sinus.
The aim of this study is to test whether an increase in coronary sinus pressure leads to a change in coronary microvascular resistances in patients with angina pectoris and with an indication to measurement of microvascular function as per clinical guidelines.
All patients with a clinical indication for the assessment of microvascular function will be invited to participate and will sign the informed consent at least 24 hours before the study. Patients with an index of microvascular resistances >25 (i.e. evidence of microvascular dysfunction) will undergo study-specific procedures in the same session (i.e. no additional invasive procedure is required for the study).
Study-specific procedures include the repetition of the assessment of microvascular resistances at rest and during coronary sinus occlusion. Coronary sinus occlusion will be achieved by inflating a balloon sized to \~70% of the diameter of the coronary sinus. Since the implantation of a coronary sinus reducer is a therapeutic option for this type of patients, also this procedure (inflation of an undersized balloon in the coronary sinus) provides clinically relevant information (sizing of the vessel, effect on microvascular resistances and feasibility of the intervention).
The primary goal of the study is to study the effect of coronary sinus occlusion on microvascular resistances at rest and during hyperemia.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 20 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Johannes Gutenberg University Mainz is the lead sponsor of 153 studies on the registry; 20 are open to participants now.
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The index of microvascular resistances will be measured while a balloon placed in the coronary sinus is kept deflated.
Device: Swan-Ganz catheter placed in the coronary sinus - deflated
The index of microvascular resistances will be measured while a balloon placed in the coronary sinus is inflated.
Device: Swan-Ganz catheter placed in the coronary sinus - inflated
A normal Swan-Ganz catheter will be advanced in the coronary sinus. The Balloon will be kept deflated during sham intervention. The index of microvascular resistances will be measured using the Abbott Pressure Wire X as per instructions for use durng both interventions.
A normal Swan-Ganz catheter will be advanced in the coronary sinus. The Balloon will be inflated to obtain coronary sinus occlusion during the active intervention. The index of microvascular resistances will be measured using the Abbott Pressure Wire X as per instructions for use durng both interventions.
Index of microvascular resistances (balloon occlusion versus deflated balloon)
The Index of microvascular resistances, calculated as (Pressure distal - coronary venous pressure ) x mean transit time, will be compared between the two arms
Time frame: 1 Minute after balloon occlusion
Plan to share: No
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Johannes Gutenberg University Mainz