Evaluation of Coronary Microvascular Dysfunction (EVACORY)

NCT01995955 | Completed DMC

• 1 other identifier: 2012-A00986-37
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is to validate a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease with a comparison with validated technique invasive, which is measure of index of myocardial resistance.

Conditions

Coronary Artery Disease

Keywords

Coronary Microvascular Dysfunction; coronary artery disease; index of myocardial resistance

Outcome Measures

Primary Outcomes (1)

• coronary microcirculation

  IMR was measured with commercially available software (St Jude Medical Systems) and thermodilution technique on a non-ischemic artery SPECT. Injections of 3 mL of room-temperature saline were made down the coronary artery, and the resting mean transit time (Tmn) was measured. CFR was calculated as resting Tmn divided by hyperemic Tmn. FFR was calculated by the ratio of Pd/Pa at maximal hyperemia.IMR was defined as distal coronary pressure multiplied by the hyperemic mean transit time (mm Hg • seconds, or units \[U\]). Myocardial Heterogeneity Index (Hi) was measured by an automated analysis developed in our research unit. Hi was finally calculated from images SPECT using a Markovian analysis. For this study Hi is given by the equation: Hi = Σm \[1/(1+m)2\]Pd(m).

  day 0 (inclusion)

Secondary Outcomes (1)

• scintigraphy

  day 0 (inclusion)

Study Arms (1)

a new non-invasive imaging technique

EXPERIMENTAL

a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease

Procedure: a new non-invasive imaging technique

Interventions

a new non-invasive imaging technique PROCEDURE

a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease

a new non-invasive imaging technique

Eligibility Criteria

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

You may qualify if:

• Stable angina
• Cadmium-zinc-telluride gamma camera SPECT
• Coronarography

You may not qualify if:

• Pregnant woman
• Patient with terminal illness,
• Terminal Renal failure
• Allergy to iodine
• Contraindications for adenosine: Asthmatic patients, Second- or third-degree AV block without a pacemaker or sick sinus syndrome, Systolic blood pressure less than 90mm Hg, Recent use of dipyridamole or dipyridamole-containing medications, Methyl xanthenes such as aminophylline caffeine or theobromine block the effect of adenosine and should be held for at least 12 hours prior to the test, Known hypersensitivity to adenosine, Unstable acute myocardial infarction or acute coronary syndrome

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital of Grenoble

Grenoble, Isère, 38700, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• BARONE ROCHETTE MD Gilles

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 27, 2013
• Study Start: June 24, 2013
• Primary Completion: December 10, 2016
• Study Completion: April 1, 2018
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

FR (1)