Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome

NCT05865600 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2025-12-10

No results posted yet for this study

Summary

We will establish a cohort of 570 symptomatic chronic coronary syndrome patients undergoing 15O-water PET and assess their symptoms through repeated questionnaires. Two hundred patients with abnormal perfusion will be randomized to immediate or delayed referral to invasive coronary angiography with concomitant optimization of guideline-directed medical therapy with repeated 15O-water PET and questionnaires at 3 and 6 months. The primary objective is to compare the potential benefit of early invasive coronary angiography (ICA) versus guideline directed medical therapy (GDMT) on symptomatic relief defined as freedom of angina after 3 months following a positive \[15O\]H2O cardiac PET/CT in patients with symptomatic chronic coronary syndrome.

Conditions

Interventions

OTHER

Optimization of guideline-directed medical therapy

Consultation every second week with optimization of guideline-directed medical therapy according to 2019 ESC guidelines on chronic coronary syndrome. Focus will be on risk-factor modification and anti-anginal medication with the treatment aim to achieve freedom from angina and dyspnea with a heart rate at rest ≤ 60 beats/min and systolic blood pressure \> 100 mmHg.

DIAGNOSTIC_TEST

Immediate referral for invasive coronary angiography

Immediate referral for invasive coronary angiography

DIAGNOSTIC_TEST

3-months delayed referral for invasive coronary angiography

3-months delayed referral for invasive coronary angiography

OTHER

Standard of care

Standard of care

Sponsors & Collaborators

  • Gødstrup Hospital

    lead OTHER

Principal Investigators

  • Morten Böttcher, Prof · University Clinic for Cardiovascular Research, Dept. of Cardiology, Gødstrup Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2026-09-01
Completion
2027-09-01

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05865600 on ClinicalTrials.gov