Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05178914

Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina

Led by University Hospital, Grenoble · Updated on 2024-06-24

280

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The evidence demonstrating the importance of coronary microcirculation in the management of patients with coronary artery disease is growing. For example, in recent years, a number of studies have demonstrated that the presence of coronary microvascular disease (CMVD) contributes to increased cardiovascular morbidity and mortality independent of the extent and severity of coronary epicardial disease. The index of microcirculatory resistance (IMR) is an invasive index proposed for the diagnosis of CMVD. The ability of IMR to motivate therapeutic changes in order to subsequently reduce symptoms and improves the quality of life of our patients with stable coronary artery disease (CAD) was recently demonstrated. The prognostic value of IMR has also been shown in stable CAD with PCI. Thus, after optimal epicardial evaluation and if necessary revascularization according to FFR, IMR could represent a tool for personalized medicine adapted to the presence of severe CMVD. The aim of the study is to demonstrate a positive effect of personalized medicine on angina in patients with epicardial coronary network lesion assessment by FFR and with significant CMVD assessed by IMR.

CONDITIONS

Official Title

Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient over 18 years
  • Symptomatology of angina pectoris
  • Receiving invasive coronary angiography
  • FFR and microcirculatory resistance index (MRI) measurement for at least one epicardial lesion 28 50%
  • For lesions with FFR 28 0.8, revascularization with the XIENCE Sierra stent and its evolutions will be performed
  • Optimization of epicardial revascularization evidenced by post-PCI FFR > 0.8 on all major trunks or absence of 28 50% stenosis on two orthogonal views by quantitative coronary angiography at the revascularization site
  • For lesions with FFR > 0.8 revascularization will not be performed
  • Written informed consent
Not Eligible

You will not qualify if you...

  • A non-coronary indication for coronary angiography, e.g. valve disease, hypertrophic obstructive cardiomyopathy
  • Severe renal dysfunction (GFR < 30 ml/min)
  • Contraindications for adenosine including asthma, second or third degree AV block without pacemaker, sick sinus syndrome, systolic blood pressure less than 90 mm Hg, recent use of dipyridamole or related drugs, methyl xanthenes such as caffeine, aminophylline or theobromine
  • Known hypersensitivity to adenosine
  • Pregnant women, parturients and breastfeeding mothers
  • Persons under legal protection measures or unable to express consent
  • Patient in a period of exclusion from another study
  • Patient under administrative or judicial supervision

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

CHU Grenoble Alpes

La Tronche, France, 38700

Actively Recruiting

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Research Team

G

Gilles Barone Rochette

CONTACT

C

Clémence Charlon

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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