Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment (ASPERA-ANOCA)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Microvascular Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: microvascular function assessment

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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tommaso Gori, MD, PhD; Phone Number: 00496131172829; Email: tomgori@hotmail.com

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: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous Adenosine; Invasive microvascular function assessment will be conducted by administering intravenous hyperemic agent adenosine.	Diagnostic test: microvascular function assessment; mircovascular function parameters will be measured by administering adenosine in two different pathways
Experimental: Intracoronary Adenosine; Invasive microvascular function assessment will be conducted by administering intracoronary hyperemic agent adenosine.	Diagnostic test: microvascular function assessment; mircovascular function parameters will be measured by administering adenosine in two different pathways

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time required for IMR measurements	Comparison of time required for measuring IMR between intracoronary and intravenous adenosine administration	6 months

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Tommaso Gori, MD,PhD, Center of Cardiology, Cardiology I, University Medical Center Mainz

Study record dates

Study Major Dates

• Study Start (Estimated): March 2, 2024
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: adenosine; microvascular disease; coronary microvascular assessment
• 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: ASPERA-ANOCA; 20240124 (Other Identifier: JohannesGU)

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