IMR Assessment in Patients With New Diagnosis of Left Ventricle Dilatation

Cardiomyopathies Clinical Trial

— IMPAIRED  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705170
• Other study ID #: 260480
• Status: Completed
• Start date: March 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2018
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 30, 2018
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Microcirculation
• Microvessels

Intervention

Procedure:
• index of microvascular resistance
Measurement of the index of microvascular resistance in the left anterior descending artery

Locations

Country	Name	City	State
Italy	University Hospital of Ferrara	Cona	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	all-cause death	occurrence of all-cause death at 1 year	1-year
Other	heart failure	occurrence of hospital admission for heart failure	1-year
Primary	Index of microcirculatory resistance	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	cardiac death	occurrence of cardiac death at 1 year	1-year