IMR Assessment in Patients With New Diagnosis of Left Ventricle Dilatation

NCT ID: NCT02705170

Last Updated: 2018-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Cardiomyopathies Microcirculation Microvessels

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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left ventricle dilatation

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.

index of microvascular resistance

Intervention Type PROCEDURE

Measurement of the index of microvascular resistance in the left anterior descending artery

Interventions

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index of microvascular resistance

Measurement of the index of microvascular resistance in the left anterior descending artery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Gianluca Campo

Assistant Professor, Interventional Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gianluca Campo, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Universitaria di Ferrara

Locations

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University Hospital of Ferrara

Cona, Ferrara, Italy

Site Status

Countries

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Italy

Other Identifiers

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260480

Identifier Type: -

Identifier Source: org_study_id

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