N/A
N=1,216
Role of On-site CT-derived FFR in the Management of Suspect CAD Patients
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03901326 ↗Enrolled (actual)
1,216
Serious AEs
3.3%
Results posted
May 2024
Primary outcome: Primary: Number of Participants With ICA Without Obstructive CAD or Intervention — 421; 483; 119; 223 Participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CT-FFR assessment (Diagnostic_test)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Chinese PLA General Hospital
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With ICA Without Obstructive CAD or Intervention |
421; 483; 119; 223; 88; 184 | 0.05 |
| SECONDARY Number of Participant With Major Adverse Cardiovascular Event |
48; 54 | 0.80 |
| SECONDARY Medical Expenditure |
47032; 51265 | 0.07 |
| SECONDARY Patient Reporting Outcomes |
57.6; 57.4; 73.8; 72.3; 81.4; 80.7 | 0.15 |
| SECONDARY Cumulative Radiation Exposure |
— | — |
Summary
The primary of this registry is to evaluate whether the availability of CTA/CT-FFR procedure could effectively optimize the flow of clinical practice of stable chest pain versus conventional clinical pathway in decision making, avoid the overuse of invasive procedure, finally improve clinical prognosis and reduce total medical expenditure. This registry is randomized, open labeled, prospective designed and will be performed in 6 Chinese hospitals. Approximately 1200 subjects will be enrolled and subsequently assigned to either routine clinically-indicated diagnostic care group (CID arm) or CTA/CT-FFR care group (CTA/CT-FFR arm) via computer-generated random numbers (1:1 ratio)
Eligibility Criteria
Inclusion Criteria
- New-onset chest pain suspicious for CAD
- Coronary CTA result showed that the diameter stenosis is between 30 and 90% in at least one major coronary artery (coronary artery diameter ≥ 2.5 mm)
- Intermediate-to-high pretest probability of CAD based on CAD Consortium Score
- No prior evaluation for this episode of symptoms
- Agree to participate in this clinical study and sign written informed consent
Exclusion Criteria
- Diagnosed or suspected acute coronary syndrome requiring hospitalization or emergent testing
- Hemodynamically or clinically unstable condition systolic blood pressure 90%
- Known severe congenital, valvular (moderate and above), or cardiomyopathy process (hypertrophic cardiomyopathy or reduced systolic left ventricular function ≤ 40%) which could explain cardiac symptoms
- Unable to provide written informed consent or participate in long-term follow-up.
Data sourced from ClinicalTrials.gov (NCT03901326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.