IMPAIRED: IMR Assessment in Patients With New Diagnosis of Left Ventricle Dilatation

Sponsor

University Hospital of Ferrara (Other)

Overall Status

Completed

CT.gov ID

NCT02705170

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cardiomyopathies Microcirculation Microvessels	Procedure: index of microvascular resistance

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 Design

Study Type:

Observational

Actual Enrollment :

35 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Index of Microcirculatory Resistance (IMR) Assessment in Patients With New Diagnosis of Left Ventricular Dilatation Without Significant Coronary Artery Lesions: IMPAIRED Pilot Trial

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Nov 2, 2017

Actual Study Completion Date :

Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: index of microvascular resistance Measurement of the index of microvascular resistance in the left anterior descending artery

Arm

Intervention/Treatment

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.

Procedure: index of microvascular resistance

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

Outcome Measures

Primary Outcome Measures

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

cardiac death [1-year]
occurrence of cardiac death at 1 year

Other Outcome Measures

all-cause death [1-year]
occurrence of all-cause death at 1 year
heart failure [1-year]
occurrence of hospital admission for heart failure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Ferrara	Cona	Ferrara	Italy	44124

Sponsors and Collaborators

University Hospital of Ferrara

Investigators

Principal Investigator: Gianluca Campo, MD, Azienda Ospedaliera Universitaria di Ferrara

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gianluca Campo, Assistant Professor, Interventional Cardiologist, University Hospital of Ferrara

ClinicalTrials.gov Identifier:

NCT02705170

Other Study ID Numbers:

260480

First Posted:

Mar 10, 2016

Last Update Posted:

May 2, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Gianluca Campo, Assistant Professor, Interventional Cardiologist, University Hospital of Ferrara

index of microvascular resistance

Additional relevant MeSH terms:

Cardiomyopathies

Study Results

No Results Posted as of May 2, 2018