Coronary Sinus Pressure and Microvascular Disease (MACCUS)

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

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.

Study Overview

• Status: Completed
• Conditions: Microvascular Coronary Artery Disease
• Intervention / Treatment: Device: Swan-Ganz catheter placed in the coronary sinus - deflated; Device: Swan-Ganz catheter placed in the coronary sinus - inflated

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Center of Cardiology, Cardiology I, university hospital Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham; 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; 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.
Active Comparator: Coronary sinus occlusion; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 Minute after balloon occlusion

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): August 23, 2023
• Study Completion (Actual): August 23, 2023

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2021-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No