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

J

Johannes Gutenberg University (JGU)

Status

Not yet enrolling

Conditions

Microvascular Coronary Artery Disease

Treatments

Diagnostic Test: microvascular function assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT06269874
ASPERA-ANOCA
20240124 (Other Identifier)

Details and patient eligibility

About

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

Full 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: Agreement and reproducibility of FFR, CFR, MRR, RRR and reproducibility of each of these as compared with CFRabs. Time required for IMR measurements Presence and severity of angina, assessed by SAQ(Seattle Angina Questionnaire)-7 Assessment of safety: Presence and severity of AV( atrioventricular) block, dyspnea, flush

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Intravenous Adenosine
Active Comparator group
Description:
Invasive microvascular function assessment will be conducted by administering intravenous hyperemic agent adenosine.
Treatment:
Diagnostic Test: microvascular function assessment
Intracoronary Adenosine
Experimental group
Description:
Invasive microvascular function assessment will be conducted by administering intracoronary hyperemic agent adenosine.
Treatment:
Diagnostic Test: microvascular function assessment

Trial contacts and locations

1

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Central trial contact

Tommaso Gori, MD, PhD

Data sourced from clinicaltrials.gov

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