IMR Assessment in Patients With New Diagnosis of Left Ventricle Dilatation

NCT02705170 | Completed DMC

• 1 other identifier: 260480
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiomyopathies; Microcirculation; Microvessels

Keywords

index of microvascular resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• cardiac death

  1-year

Other Outcomes (2)

• all-cause death

  1-year

• heart failure

  1-year

Study Arms (1)

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

Interventions

index of microvascular resistance PROCEDURE

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

left ventricle dilatation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• new diagnosis of left ventricular dilation (dilatative cardiopathy)
• absence of significant (\>40%) coronary artery disease at coronary artery angiography

You may not qualify if:

• history of ischemic heart disease
• history of significant valvular disease
• contraindication to hyperemic agent

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Gianluca Campo, MD

  Azienda Ospedaliera Universitaria di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Interventional Cardiologist

Study Record Dates

• First Submitted: March 5, 2016
• First Posted: March 10, 2016
• Study Start: March 1, 2016
• Primary Completion: November 2, 2017
• Study Completion: April 30, 2018
• Last Updated: May 2, 2018

Record last verified: 2018-05

Locations

IT (1)