Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment

NCT06269874 | Not Yet Recruiting

• 2 other identifiers: ASPERA-ANOCA20240124
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR (Index of microvascular resistance) value.
2. 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. 3.Time required for IMR measurements

Conditions

Microvascular Coronary Artery Disease

Keywords

adenosine; coronary microvascular assessment; microvascular disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Agreement between secondary parameters and reproducibility as compared with absolute

  6 months

• Time required for IMR measurements

  6 months

Study Arms (2)

Intravenous Adenosine

ACTIVE COMPARATOR

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

Diagnostic Test: microvascular function assessment

Intracoronary Adenosine

EXPERIMENTAL

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

Diagnostic Test: microvascular function assessment

Interventions

microvascular function assessment DIAGNOSTIC_TEST

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

Intracoronary Adenosine; Intravenous Adenosine

Eligibility Criteria

• Age: 18 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).
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Study Officials

• Tommaso Gori, MD,PhD

  Center of Cardiology, Cardiology I, University Medical Center Mainz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommaso Gori, MD, PhD

CONTACT

00496131172829; tomgori@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and outcome assessors will be blinded to the randomization group.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomized 1:1 to one of the two study arms and then the following study procedures will repeated in cross-over. Randomization will be done by using a computer-generated random sequence (medcalc, mariakerke, BE).

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start (Estimated): March 2, 2027
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)