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

NCT05178914 | Recruiting

• 1 other identifier: 38RC21.0339
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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

Coronary Microvascular Disease

Keywords

index of microcirculatory resistance

Outcome Measures

Primary Outcomes (1)

• The mean difference in angina severity

  Assessed by the Seattle Angina Questionnaire summary score) between patients with an IMR ≥ 25 in the interventional group, benefiting from personalized medicine, and patients with IMR ≥ 25 in the control group benefiting from standard care

  One year

Secondary Outcomes (11)

• To demonstrate a positive effect of personalized medicine guided by IMR assessment on physical limitation due to angina

  At 6 months and 1 year

• To demonstrate a positive effect of personalized medicine guided by IMR assessment on stability of angina

  At 6 months and 1 year

• To demonstrate a positive effect of personalized medicine guided by IMR assessment on frequency of angina

  At 6 months and 1 year

• To demonstrate a positive effect of personalized medicine guided by IMR assessment on perception of the disease.

  At 6 months and 1 year

• To demonstrate a positive effect of personalized medicine guided by IMR assessment with satisfaction with the treatment.

  At 6 months and 1 year

Study Arms (2)

The interventional group

EXPERIMENTAL

Patients are defined by the disclosure of the IMR value. The initial IMR is used to guide therapy. For patients with initial IMR ≥ 25 will benefit from intensified coronary artery disease treatment to manage the microcirculatory damage according to the recommendations and consensus of European experts. For patients with a initial IMR \< 25 will benefit from de-escalade therapeutic adaptation.

Procedure: Treatment adaptation

The control group

SHAM COMPARATOR

The control group is defined as follows: the initial IMR has been performed but its result is not undisclosed (sham procedure) ; patients will receive standard medical treatment according to the physician's preference.

Procedure: Treatment adaptation

Interventions

Treatment adaptation PROCEDURE

Patients will benefit from intensified treatment or de escalation treatment according to the result of the index of microcirculatory resistance

The control group; The interventional group

Eligibility Criteria

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

You may qualify if:

• 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 ≥ 50% :
• For lesions with FFR ≤ 0.8, revascularization with the XIENCE Sierra stent and its evolutions will be performed. Optimization of this epicardial revascularization will be evidenced by a post-PCI FFR \> 0.8 on all major trunks and if an FFR measurement is not performed, absence of 50% or greater stenosis on two orthogonal views by quantitative coronary angiography \[QCA\] at the revascularization site.
• For lesions with FFR \> 0.8 revascularization will not be performed
• Written informed consent

You may not qualify if:

• A non-coronary indication for coronary angiography, e.g. valve disease, hypertrophic obstructive cardiomyopathy.
• Severe renal dysfunction (GFR \< 30 ml/min)
• Contraindications for adenosine: asthma, Second or third degree AV block without pacemaker or sick sinus syndrome, Systolic blood pressure less than 90 mm Hg, Recent use of dipyridamole or drugs containing dipyridamole, Methyl xanthenes such as caffeine aminophylline or theobromine block the effect of adenosine and should be stored at least 12 hours before testing, Known hypersensitivity to adenosine.
• Pregnant women, parturients and breastfeeding mothers
• Persons of full age who are subject to a legal protection measure or who are unable to express their consent
• Patient under administrative or judicial supervision

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

La Tronche, 38700, France

RECRUITING

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Gilles Barone Rochette

CONTACT

+33476765172; gbarone@chu-grenoble.fr

Clémence Charlon

CONTACT

+33476766652; ccharlon@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with a symptomatology of angina pectoris who have at least one epicardial lesion greater than or equal to 50% on coronary angiography evaluation The interventional group is defined by the disclosure of the IMR value. The initial IMR is used to guide therapy. The control group is defined as follows: the initial IMR has been performed but its result is not undisclosed (sham procedure) ; patients will receive standard medical treatment according to the physician's preference.

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: January 5, 2022
• Study Start: March 31, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)