Viewing Study NCT06281067



Ignite Creation Date: 2024-05-06 @ 8:11 PM
Last Modification Date: 2024-10-26 @ 3:22 PM
Study NCT ID: NCT06281067
Status: RECRUITING
Last Update Posted: 2024-07-10
First Post: 2024-02-15

Brief Title: Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine
Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Organization: Azienda Ospedaliero Universitaria Maggiore della Carita

Study Overview

Official Title: Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine RIALTO PRO
Status: RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: RIALTO PRO
Brief Summary: The RIALTO-PRO study aims to optimize the diagnostic and therapeutic algorithm for myocardial bridge MB patients testing the diagnostic value of a full invasive diagnostic procedure and consequently the prognostic value of a tailored approach the study objective is to determine the diagnostic and prognostic value of a full-physiology approach strategy versus a standard approach strategy in patients with a MB

The RIALTO PRO study is a randomized multicentre prospective open-label superiority trial comparing a personalised versus standard management in patients with MB Consenting and eligible patients will be randomised 11 to either a full-physiology approach consisting of a comprehensive diagnostic algorithm aimed at unmasking the main pathophysiological mechanism of myocardial ischemia and consequently a tailored treatment or a standard approach consisting of angiographic evaluation of the tunnelled segment
Detailed Description: TRIAL PROCEDURES Once MB is angiographically detected eligible and consenting patients will be randomly assigned in a 11 ratio to receive a standard approach or a full-physiology approach during index CA

Index coronary angiography Coronary angiography will be performed through a radial or femoral approach Unfractionated heparin initial weight-adjusted intravenous bolus of 50-70 IUkg with repeat boluses to achieve an activated clotting time 250 will be administered in all patients To fully expose all segments of the coronary arteries at least 2 perpendicular projections for the right coronary artery RCA and 4 projections for the LAD will be taken Intracoronary nitrates can be used depending on blood pressure and in any case at the discretion of the Investigator to increase the angiographic sensitivity in detecting the milking effect

Physiological epicardial and microvascular assessment MB hemodynamic assessment will be performed using a diagnostic guidewire placed in the index vessel Intravenous heparin 50-70 Ukg should be administered to achieve therapeutic anticoagulation activated clotting time 250 s The innovative Abbott PressureWire X Guidewire will be used to measure pressure and temperature The guidewires wireless measurements are connected to an advanced platform Coroventis CoroFlow Cardiovascular System to measure physiological indices Abbotts PressureWire X Guidewire and Coroventis CoroFlow Cardiovascular System are nowadays the only solution for the cath lab able to assess both epicardial vessel ie FFR 080 and microcirculation ie CFR 20 and IMR 25

Epicardial assessment will include

Resting PdPa nv 092
FFR after intravenous adenosine administration nv 080
RFR nv 089
FFR after intravenous dobutamine administration nv 075 FFR is defined as the mean distal pressure Pdmean aortic pressure Pa across MB during maximal hyperemia achieved by administration of intravenous 140 μgkgmin or intracoronary bolus up to 200 µg of adenosine PdPa was automatically calculated by current computational software as the ratio found in the pressure recording A cut-off of 080 will be used to detect hemodynamic relevance Inotropic stimulation to exalt the hemodynamic significance of MB will be performed with intravenous dobutamine infusion in case of a negative functional assessment PdPa 092 FFR 080 RFR 089 The infusion will be started at 5 μgkgmin and increased by 5μgkgmin every 5 minutes up to 20 μgkgmin or until the patient develops symptoms or clear evidence of ischemia An intravenous infusion of 1 mg atropine will be administered if the patient will not experience symptoms or signs of myocardial ischemia with 20 μgkgmin of dobutamine infusion An intravenous bolus of β-blocker ie metoprolol 5 mg will be administered at the end of the procedure to antagonize the effects of dobutamine

Microvascular assessment will include

basal CFR nv 20 and CFR after intravenous dobutamine administration CFR-d
basal IMR nv 25 and IMR after intravenous dobutamine administration IMR-d The coronary flow reserve and the microcirculatory resistance will be calculated using thermodilution thanks to the PressureWire X Guidewire The thermodilution-based CFR cut-off value is 20 It is the ratio of the maximal or hyperemic flow down a coronary vessel to the resting flow IMR is calculated as the product of distal coronary pressure at maximal hyperaemia multiplied by the hyperaemic mean transit time Reduced CFR 20 and increased IMR 25 are representative of structural microvascular dysfunction impaired endothelium-independent vasodilatation

ACH provocative test In order to unmask MB-related epicardial andor microvascular CAS ACH provocative test will be performed in case of absence of epicardial hemodynamic significance and structural microvascular dysfunction Incremental doses of 20 50 100 and 200 μg of ACH will be infused over a period of 2 minutes into the index vessel vessel with angiographic milking effect via the angiographic catheter repeating CA after each Ach dose The test will be performed with a continuous monitoring of symptoms electrocardiogram ECG and angiographic evidence of spasm Angiographic responses during the provocation test will be assessed in multiple orthogonal views to detect the artery spasm If either complications andor a positive response occurred the test will be discontinued and higher doses will be not administered The test will be considered positive for epicardial CAS in the presence of focal or diffuse epicardial coronary diameter reduction 90 in comparison with the relaxed state following intracoronary nitroglycerine administration given to relieve the spasm associated with the reproduction of the patients anginal symptoms and ischemic ECG shifts Microvascular spasm will be diagnosed when typical ischemic ST-segment changes and angina develop in the absence of epicardial coronary constriction 90 diameter reduction Patients who will not experience angina spasm or ST-segment shifts will be considered to have a negative test response normal coronary vasoreactivity Similarly patients who will experience ischemic ECG shifts without angina or patients with chest pain without ischemic ECG shifts will be considered to have a negative test response

Statistical analysis Statistical analysis will be performed using statistical software package Statistic for Data Analysis Stata 17 64 bit StataCorp College Station TX and GraphPad Prism version 802 GraphPad Software San Diego CA Chi-square Fishers exact test and Kruskal Wallis test will be used to compare categorical variables Continuous variables were listed as mean standard deviation SD and will be compared between groups using the Students t-test the Mann-Whitney U test as appropriate We will perform a 2-tailed analysis and consider a p-value 005 to be significant With respect to the primary endpoint all events occurring from randomization to the study end date will be counted The number and rate of patients experiencing a primary endpoint will also be summarized The proportion of patients remaining event-free over time will be displayed in the form of survival curves using the Kaplan-Meier method and analyzed using the log-rank test and the Gehan-Breslow-Wilcoxon test With respect to secondary endpoints a Cox proportional hazards model will be used and estimates of the hazard ratios and their confidence intervals will be provided In general missing values will remain as missing ie no attempt will be made to impute missing values and only observed values will be used in data analyses An interim analysis will be performed on the primary endpoint when 50 of patients will have been randomized and completed the 6 months follow-up The interim analysis will be performed by an independent statistician blinded for the treatment allocation

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None