IMR Assessment in Patients With New Diagnosis of Left Ventricle Dilatation

Completed

• Conditions: Cardiomyopathies; Microcirculation; Microvessels
• Interventions: Procedure: index of microvascular resistance

• Registration Number: NCT02705170
• Lead Sponsor: University Hospital of Ferrara

Brief Summary

To establish if, in patients with new diagnosis of left ventricular dilatation without documentation at the coronary artery angiography of significant coronary artery lesions, there is a damage of the coronary microcirculation at the IMR (index of microcirculatory resistance) assessment

Detailed Description

The Authors will enroll at the moment of coronary artery angiography patients without history of ischemic heart disease and new diagnosis (at transthoracic echocardiography) of left ventricular dilation.

All patients will undergo coronary artery angiography. To be enrolled, it is necessary to have the absence of significant coronary artery stenosis (angiographic evaluation of the lesion \>40%) in all the vessels (main and side branch).

The Authors will proceed to perform the evaluation of the index of microvascular resistance (IMR). The target vessel will be the left anterior descending artery.

An intracoronary pressure/temperature sensor-tipped guidewire will be used. Thermodilution curves will be obtained during maximal hyperemia. The IMR will be calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-05
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-10
• Primary Completion: 2017-11-02
• Study Completion: 2018-04-30
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• new diagnosis of left ventricular dilation (dilatative cardiopathy)
• absence of significant (>40%) coronary artery disease at coronary artery angiography

Exclusion Criteria

• history of ischemic heart disease
• history of significant valvular disease
• contraindication to hyperemic agent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
left ventricle dilatation	index of microvascular resistance	The subjects of the investigation will be patients with recent diagnosis of unknown left ventricle dilatation. These subjects received coronary artery angiography as exam suggested by guidelines to discriminate the cause of left ventricle dilatation. In subjects without documentation of coronary artery lesions, the Authors will assess the index of microvascular resistance.

Primary Outcome Measures

Name	Time	Method
Index of microcirculatory resistance	during coronary artery angiography	Measurement of IMR in the left anterior descending artery of patients with new diagnosis of left ventricular dilatation and no significant stenosis in epicardial coronary arteries

Secondary Outcome Measures

Name	Time	Method
cardiac death	1-year	occurrence of cardiac death at 1 year

Trial Locations

Locations (1)

University Hospital of Ferrara; 🇮🇹 Cona, Ferrara, Italy