Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment

NCT ID: NCT06269874

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-03-02
• Study Completion Date: 2027-08-31

Brief Summary

The aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function.

Goals of this study are:

1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR (Index of microvascular resistance) value.

2. Agreement and reproducibility of FFR(fractional flow reserve), CFR (coronary flow reserve), MRR (microvascular resistance reserve), RRR (resistive reserve ratio) and reproducibility of each of these as compared with CFRabs (absolute coronary flow).

3. Time required for IMR measurements

Detailed Description

The study is a single-center randomized, cross-over controlled, open label trial to investigate the reproducibility and agreement between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function.

The primary analysis will be on the per-protocol population (i.e. including all patients who are not protocol violators).

Primary endpoint:

1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR value.

Secondary endpoints:

1. Agreement and reproducibility of FFR, CFR, MRR, RRR and reproducibility of each of these as compared with CFRabs.

2. Time required for IMR measurements

3. Presence and severity of angina, assessed by SAQ(Seattle Angina Questionnaire)-7

4. Assessment of safety: Presence and severity of AV( atrioventricular) block, dyspnea, flush

Conditions

Microvascular Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Intravenous Adenosine

Invasive microvascular function assessment will be conducted by administering intravenous hyperemic agent adenosine.

Group Type: ACTIVE_COMPARATOR

microvascular function assessment

Intervention Type: DIAGNOSTIC_TEST

mircovascular function parameters will be measured by administering adenosine in two different pathways

Intracoronary Adenosine

Invasive microvascular function assessment will be conducted by administering intracoronary hyperemic agent adenosine.

Group Type: EXPERIMENTAL

microvascular function assessment

Intervention Type: DIAGNOSTIC_TEST

mircovascular function parameters will be measured by administering adenosine in two different pathways

Interventions

microvascular function assessment

mircovascular function parameters will be measured by administering adenosine in two different pathways

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Chronic coronary syndrome (including patients with anginal equivalents).
• 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)
• Willingness to participate and ability to understand, read and sign the informed consent
• Age>18 years

Exclusion Criteria

• Age <18 years
• Bronchial asthma, COPD (chronic obstructive pulmonary disease)
• Secondary or tertiary atrioventricular block without prior pacemaker implantation
• Previous CABG (coronary artery bypass graft) 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
• Inability to provide informed consent

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

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Tommaso Gori

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tommaso Gori, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Center of Cardiology, Cardiology I, University Medical Center Mainz

Locations

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, Germany

Countries

Germany

Central Contacts

Tommaso Gori, MD, PhD

Role: CONTACT

tomgori@hotmail.com

00496131172829

Other Identifiers

20240124

Identifier Type: OTHER

Identifier Source: secondary_id

ASPERA-ANOCA

Identifier Type: -

Identifier Source: org_study_id