Coronary Sinus Pressure and Microvascular Disease

NCT ID: NCT05034224

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-23
• Study Completion Date: 2023-08-23

Brief Summary

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.

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.

Conditions

Microvascular Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Sham

The index of microvascular resistances will be measured while a balloon placed in the coronary sinus is kept deflated.

Group Type: SHAM_COMPARATOR

Swan-Ganz catheter placed in the coronary sinus - deflated

Intervention Type: 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.

Coronary sinus occlusion

The index of microvascular resistances will be measured while a balloon placed in the coronary sinus is inflated.

Group Type: ACTIVE_COMPARATOR

Swan-Ganz catheter placed in the coronary sinus - inflated

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Tommaso Gori

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, Germany

Countries

Germany

References

Ullrich H, Hammer P, Olschewski M, Munzel T, Escaned J, Gori T. Coronary Venous Pressure and Microvascular Hemodynamics in Patients With Microvascular Angina: A Randomized Clinical Trial. JAMA Cardiol. 2023 Oct 1;8(10):979-983. doi: 10.1001/jamacardio.2023.2566.

Reference Type: DERIVED

PMID: 37610757 (View on PubMed)

Ullrich H, Olschewski M, Munzel T, Gori T. Randomized, crossover, controlled trial on the modulation of cardiac coronary sinus hemodynamics to develop a new treatment for microvascular disease: Protocol of the MACCUS trial. Front Cardiovasc Med. 2023 Feb 16;10:1133014. doi: 10.3389/fcvm.2023.1133014. eCollection 2023.

Reference Type: DERIVED

PMID: 36873411 (View on PubMed)

Other Identifiers

2021-4

Identifier Type: -

Identifier Source: org_study_id