Comparison of FFR, CT-FFR, QFR and RFR measurement methods in patients with coronary artery disease heart disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00022842

Enrollment

655

Registered

2020-12-29

Start date

2021-01-06

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I25.9

Interventions

Group 1: Patients who underwent cardiac catheterization with assessment of the functional significance of coronary stenosis using fractional flow reserve (FFR) or resting full-cycle ratio (RFR) are i

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Coronary angiography with FFR or RFR assessment.

Exclusion criteria

Exclusion criteria: Incomplete recordings of pressure waves in aorta and coronary arteries before and after adenosine administration.

Design outcomes

Primary

Measure	Time frame
Diagnostic performance (accuracy, sensitivity, specificity, positive and negative predictive value of the measurement methods, receiver operating curve characteristics, correlation analysis). Incidence of complications according to the measurement methods (VOCOs (vessel-oriented composite outcome): Myocardial infarction, repeat revascularization, cardiac death).	—

Secondary

Measure	Time frame
- Target vessel failure at 12/24/60 months (A composite of cardiac death, target vessel myocardial infarction, and ischemic-related target vessel revascularization). - All-cause mortality at 12/24/60 months (All-cause mortality includes cardiac death and other cause-of-death categories such as cerebrovascular death, death from other cardiovascular disease (ie, pulmonary embolism, aortic dissection, aortic aneurysm), death from malignancy, death from suicide, violence, or accident, or death from other causes) - Cardiac death after 12/24/60 months (Includes death due to coronary artery disease including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death due to heart failure including cardiogenic shock, and death related to cardiac surgery within 30 days of surgery. If death is not clearly attributable to other noncardiac causes, it is considered a cardiac death). - Myocardial infarction at 12/24/60 months. - Target vessel myocardial infarction at 12/24/60 months ("culprit lesion" of myocardial infarction in the index vessel) - any unplanned revascularization - Planned revascularizations (a revascularization is considered planned if it is decided at the time of the index procedure based on the results of angiography and functional testing is performed within the first 90 days) - Unplanned revascularization (Revascularization is considered "unplanned" if it is not performed as part of standard care or within the index procedure or is performed within 90 days) - Any ischemia-related de novo revascularization after 12/24/60 months (coronary artery bypass grafting or PCI of a vessel that was not investigated or treated during the index procedure) - Ischemia-related target vessel revascularization at 12/24/60 months (coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia) - Feasibility of QFR (percentage of successful studies using QFR) - Feas	—

Measure

Time frame

- Target vessel failure at 12/24/60 months (A composite of cardiac death, target vessel myocardial infarction, and ischemic-related target vessel revascularization). - All-cause mortality at 12/24/60 months (All-cause mortality includes cardiac death and other cause-of-death categories such as cerebrovascular death, death from other cardiovascular disease (ie, pulmonary embolism, aortic dissection, aortic aneurysm), death from malignancy, death from suicide, violence, or accident, or death from other causes) - Cardiac death after 12/24/60 months (Includes death due to coronary artery disease including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death due to heart failure including cardiogenic shock, and death related to cardiac surgery within 30 days of surgery. If death is not clearly attributable to other noncardiac causes, it is considered a cardiac death). - Myocardial infarction at 12/24/60 months. - Target vessel myocardial infarction at 12/24/60 months ("culprit lesion" of myocardial infarction in the index vessel) - any unplanned revascularization - Planned revascularizations (a revascularization is considered planned if it is decided at the time of the index procedure based on the results of angiography and functional testing is performed within the first 90 days) - Unplanned revascularization (Revascularization is considered "unplanned" if it is not performed as part of standard care or within the index procedure or is performed within 90 days) - Any ischemia-related de novo revascularization after 12/24/60 months (coronary artery bypass grafting or PCI of a vessel that was not investigated or treated during the index procedure) - Ischemia-related target vessel revascularization at 12/24/60 months (coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia) - Feasibility of QFR (percentage of successful studies using QFR) - Feas

—

Countries

Germany

Contacts

Public ContactHendrik Wienemann

Klinik III für Innere Medizin - Allgemeine und interventionelle Kardiologie, Elektrophysiologie, Angiologie, Pneumologie und internistische Intensivmedizin Universitätsklinikum Köln (AöR)

hendrik.wienemann@uk-koeln.de022147832401

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026