Multimodality Imaging and Functional Lesion Assessment in Intermediate Coronary Stenosis in Chronic Coronary Syndrome

Chronic Coronary Syndrome Clinical Trial

— MultiInter-CCS  

Official title:

Multimodality Imaging and Functional Lesion Assessment in Intermediate Grade Coronary Stenosis in Chronic Coronary Syndrome: MultiInter-CCS Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261866
• Other study ID #: MultiInter-CCS
• Status: Recruiting
• Start date: April 7, 2011
• Est. completion date: December 31, 2028

Study information

• Verified date: February 2024
• Source: Medical University of Warsaw
• Contact: Mariusz Tomaniak
• Email: mariusz.tomaniak[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.

Description:

This is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters evaluated by OCT including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis. The additional objectives include: evaluation of the impact of age, sex, diabetes mellitus, renal dysfunction on the assocation between functional and morphometric indices of coronary stenosis. We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndorme there is a positive correlation between the functional parameters and the morphometric parameters of cornary stenosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older
• Chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the Canadian Cardiovascular Society classification or positive ischemia test (exercise test, single photon emission tomography (SPECT)
• Intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography
• FFR and OCT examination of the same lesion
• The patient is willing to participate in the study and has provided a written informed consent

Exclusion Criteria:

• Acute coronary syndrome
• Proximal left main lesion
• Ostial right coronary artery lesion
• Bypass of the assessed vessel
• Contraindications for adenosine administration
• Hemodynamic instability
• Heart insufficiency in New York Heart Association (NYHA) class IV scale
• Acute renal insufficiency
• Pregnancy

Related Conditions & MeSH terms

• Chronic Coronary Syndrome
• Coronary Stenosis
• Syndrome

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis		Baseline
Primary	Correlation between fractional flow reserve (FFR) and mean lumen area within the coronary stenosis		Baseline
Secondary	Major adverse cardiovascular events		36 months