Coronary Sinus Pressure and Microvascular Disease

NCT05034224 | Completed

• 1 other identifier: 2021-4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Microvascular Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sham

SHAM COMPARATOR

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

Coronary sinus occlusion

ACTIVE COMPARATOR

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

Interventions

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.

Sham

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.

Coronary sinus occlusion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (2)

• 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.

  PMID: 37610757 DERIVED

• 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.

  PMID: 36873411 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigators performing the analysis of the data (post-hoc) and patients are blinded to the sequence of the interventions.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The study is a single-center, cross-over randomized trial to investigate the effect of coronary sinus occlusion on microvascular resistances.

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 5, 2021
• Study Start: August 23, 2021
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)