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

May 1, 2018 updated by: Gianluca Campo, University Hospital of Ferrara

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Ferrara
      • Cona, Ferrara, Italy, 44124
        • University Hospital of Ferrara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing coronary artery angiography for new diagnosis of left ventricular dilatation (dilatative cardiomyopathy)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during coronary artery angiography

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac death
Time Frame: 1-year
occurrence of cardiac death at 1 year
1-year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause death
Time Frame: 1-year
occurrence of all-cause death at 1 year
1-year
heart failure
Time Frame: 1-year
occurrence of hospital admission for heart failure
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Investigators

  • Principal Investigator: Gianluca Campo, MD, Azienda Ospedaliera Universitaria Di Ferrara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

November 2, 2017

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

March 5, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 260480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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