Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment

Microvascular Coronary Artery Disease Clinical Trial

— ASPERA-ANOCA  

Official title:

A Single-centric, ProspectivE, Randomized Controlled Study Comparing Two Administration Pathways for Adenosine During Invasive Assessment of Microvascular Function in Patients With ANOCA.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06269874
• Other study ID #: ASPERA-ANOCA
• Secondary ID: 20240124
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Johannes Gutenberg University Mainz
• Contact: Tommaso Gori, MD, PhD
• Phone: 00496131172829
• Email: tomgori[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Microvascular Coronary Artery Disease

Intervention

Diagnostic Test:
• microvascular function assessment
mircovascular function parameters will be measured by administering adenosine in two different pathways

Locations

Country	Name	City	State
Germany	Center of Cardiology, Cardiology I, university hospital Mainz	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between intravenous and intracoronary adenosine responses (IMR)	Agreement and reproducibility between IMR (index of microvascular resistance) obtained with intravenous and intracoronary adenosine administration during invasive assessment of microvascular function as assessed by Cohen´s Kappa, intraclass correlation coefficient and Bland-Altman analysis.	6 months
Secondary	Agreement between secondary parameters and reproducibility as compared with absolute	Agreement and reproducibility between secondary parameters (MRR, RRR, Pd/Pa, FFR, CFR, Ach-IMR) obtained with intravenous and intracoronary adenosine administration during invasive assessment of microvascular function as assessed by Cohen´s Kappa, intraclass correlation coefficient and Bland-Altman analysis.	6 months
Secondary	Time required for IMR measurements	Comparison of time required for measuring IMR between intracoronary and intravenous adenosine administration	6 months