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

NCT06261866 | Recruiting

• 1 other identifier: MultiInter-CCS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Coronary Syndrome

Keywords

FFR; OCT; IVUS; CCS

Outcome Measures

Primary Outcomes (2)

• Correlation between fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis

  Baseline

• Correlation between fractional flow reserve (FFR) and mean lumen area within the coronary stenosis

  Baseline

Secondary Outcomes (1)

• Major adverse cardiovascular events

  36 months

Study Arms (1)

Patients with chronic coronary syndromes identified with intermediate grade coronary stenosis

Patients chronic coronary syndrome identified with intermediate grade coronary stenosis undergo coronary angiography according to current practice and guidelines recommendations. FFR will be measured, in consistency with the guidelines and recommended clinical practice. In case of FFR \> 0.8 optimal pharmacotherapy will be prescribed; on the contrary, in case of FFR ≤ 0.8 PCI will be performed. OCT imaging will be performed with commercially available device (Abbott, C7XR Dragonfly TM LightLab Imaging Inc., MA, USA) using the non-occlusive flushing technique.

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 angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw

Warsaw, Poland

RECRUITING

Study Officials

• Mariusz Tomaniak, MD, PhD, Assoc. Prof.

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariusz Tomaniak

CONTACT

mariusz.tomaniak@wum.edu.pl

Piotr Baruś

CONTACT

piotr.barus@wum.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FESC

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: April 7, 2011
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)