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NCT06269874 | NOT YET RECRUITING | Microvascular Coronary Artery Disease

Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment
Sponsor:

Johannes Gutenberg University Mainz

Information provided by (Responsible Party):

Tommaso Gori

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

Condition or disease

Microvascular Coronary Artery Disease

Intervention/treatment

microvascular function assessment

Phase

NA

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
Estimated Enrollment : 40 participants
Masking : DOUBLE
Masking Description : Patients and outcome assessors will be blinded to the randomization group.
Primary Purpose : DIAGNOSTIC
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.
Actual Study Start Date : 2027-03-02
Estimated Primary Completion Date : 2027-07-31
Estimated Study Completion Date : 2027-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment

Location Details

NCT06269874

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Germany, Rheinland-Pfalz

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rheinland-Pfalz, Germany, 55131