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OpenTrials
Completed

NCT Number: NCT02705170

IMR Assessment in Patients With New Diagnosis of Left Ventricle Dilatation

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

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Key information

Conditions

Cardiomyopathies Cardiovascular Diseases Heart Diseases Microcirculation Microvessels

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

index of microvascular resistance

Procedure

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

Primary outcomes

  1. Index of microcirculatory resistance

    Time frame: 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 outcomes

  1. cardiac death

    Time frame: 1-year

    occurrence of cardiac death at 1 year

Other outcomes

  1. all-cause death

    Time frame: 1-year

    occurrence of all-cause death at 1 year

  2. heart failure

    Time frame: 1-year

    occurrence of hospital admission for heart failure

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

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

Acronym: IMPAIRED

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 10, 2016
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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