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Completed

NCT Number: NCT05034224

Coronary Sinus Pressure and Microvascular Disease

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic coronary syndrome (including patients with anginal equivalents).
  • Reversible ischemia on non-invasive testing, indication to cardiac catheterization;
  • Indication to the assessment of microvascular function (note: patients will be asked for participation and consented prior to the first measurement of microvascular function, which will be conducted as per clinical indication; only those with evidence of pure or mixed microvascular disease (index of microvascular resistances (IMR)>25 will proceed into the study);
  • Willingness to participate and ability to understand, read and sign the informed consent;
  • Age>18 years

Exclusion criteria

  • Previous CABG with patent grafts to the left anterior descending coronary
  • Epicardial coronary disease (FFR <0.80 with evidence of a focal stenosis) in the left anterior descending territory
  • Severe valvular heart disease
  • Any cardiomyopathy; pulmonary or renal disease
  • Inability to provide informed consent
  • Any disease reducing life expectancy

Treatment and study plan

Swan-Ganz catheter placed in the coronary sinus - deflated

Device

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.

Swan-Ganz catheter placed in the coronary sinus - inflated

Device

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.

Primary outcomes

  1. Index of microvascular resistances (balloon occlusion versus deflated balloon)

    Time frame: 1 Minute after balloon occlusion

    The Index of microvascular resistances, calculated as (Pressure distal - coronary venous pressure ) x mean transit time, will be compared between the two arms

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

MACCUS: ModulAtion of Cardiac Coronary Sinus Hemodynamics to Develop a New Treatment for microvascUlar diseaSe. A Single Center, Randomized Study.

Acronym: MACCUS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2021
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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