NCT03901326: TARGET

Role of On-site CT-derived FFR in the Management of Suspect CAD Patients

Completed NA Results posted Last updated 31 May 2024

What this trial tests

NA trial testing CT-FFR assessment in Coronary Artery Disease in 1,216 participants. Completed in 31 October 2022.

Timeline

10 May 2019

Primary endpoint
30 October 2022

31 October 2022

Quick facts

Lead sponsor	Chinese PLA General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,216
Start date	10 May 2019
Primary completion	30 October 2022
Estimated completion	31 October 2022
Sites	1 location across China

Drugs / interventions tested

• CT-FFR assessment

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Chinese PLA General Hospital

Who can join

Adults 40 to 75, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With ICA Without Obstructive CAD or Intervention Primary · 90 days

Number of those patients with planned ICA in whom no significant obstructive CAD (no stenosis≥70% by core lab quantitative analysis or invasive FFR≤0.8) is found or interventions (including stent implantation, balloon dilation and bypass graft) are performed during ICA within 90 days.

Number of patients undergoing ICA

Group	Value	95% CI
CTA/CT-FFR Care Group	421
Routine Clinically-indicated Diagnostic Care Group	483

Number of patients with ICA without obstructive CAD or intervention

Group	Value	95% CI
CTA/CT-FFR Care Group	119
Routine Clinically-indicated Diagnostic Care Group	223

Number of patients with ICA without obstructive CAD

Group	Value	95% CI
CTA/CT-FFR Care Group	88
Routine Clinically-indicated Diagnostic Care Group	184

Number of patients with ICA without intervention

Group	Value	95% CI
CTA/CT-FFR Care Group	31
Routine Clinically-indicated Diagnostic Care Group	39

Number of Participant With Major Adverse Cardiovascular Event Secondary · 12 months

Major adverse cardiovascular event include death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization

Group	Value	95% CI
CTA/CT-FFR Care Group	48
Routine Clinically-indicated Diagnostic Care Group	54

Medical Expenditure Secondary · 12 months

Overall cardiac medical expenditure by intention to treat at both 90 days and 12 months cumulatively

Group	Value	95% CI
CTA/CT-FFR Care Group	47032	± 38533
Routine Clinically-indicated Diagnostic Care Group	51265	± 41462

Patient Reporting Outcomes Secondary · Study entry, 3 months, 6 months and12 months

Patient reporting outcomes as measured by Seattle Angina Questionnaire-7(SAQ-7) Scale, use SAQ-7-item instrument that measures patient reported symptoms, function and quality of life for subjects with CAD within 12 months. The SAQ-7 score is calculated as the average of the physical limitation score, quality of life score and angina frequency score. The physical limitation score, quality of life score and angina frequency score range from 0 to 100 each. Therefore, the SAQ-7 score also ranges from 0 to 100.The higher the SAQ-7 socre, physical limitation score, quality of life score and angina f

Seattle Angina Questionnaire-7(SAQ-7) Scale in study entry

Group	Value	95% CI
CTA/CT-FFR Care Group	57.6	± 4.5
Routine Clinically-indicated Diagnostic Care Group	57.4	± 4.3

Seattle Angina Questionnaire-7(SAQ-7) Scale in 3 month

Group	Value	95% CI
CTA/CT-FFR Care Group	73.8	± 1.1
Routine Clinically-indicated Diagnostic Care Group	72.3	± 1.0

Seattle Angina Questionnaire-7(SAQ-7) Scale in 6 month

Group	Value	95% CI
CTA/CT-FFR Care Group	81.4	± 1.3
Routine Clinically-indicated Diagnostic Care Group	80.7	± 1.2

Seattle Angina Questionnaire-7(SAQ-7) Scale in 12 month

Group	Value	95% CI
CTA/CT-FFR Care Group	86.3	± 3.1
Routine Clinically-indicated Diagnostic Care Group	87	± 2.9

Physical limitation score in study entry

Group	Value	95% CI
CTA/CT-FFR Care Group	59	± 4.3
Routine Clinically-indicated Diagnostic Care Group	56.9	± 4.1

Physical limitation score in 3 month

Group	Value	95% CI
CTA/CT-FFR Care Group	73	± 1.1
Routine Clinically-indicated Diagnostic Care Group	70.1	± 0.9

Physical limitation score in 6 month

Group	Value	95% CI
CTA/CT-FFR Care Group	81.1	± 1.7
Routine Clinically-indicated Diagnostic Care Group	79.1	± 1.9

Physical limitation score in 12 month

Group	Value	95% CI
CTA/CT-FFR Care Group	88.9	± 3.3
Routine Clinically-indicated Diagnostic Care Group	88	± 2.9

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CTA/CT-FFR Care Group

Serious: 14/587 (2%)

Deaths: 2/587

Routine Clinically-indicated Diagnostic Care Group

Serious: 25/589 (4%)

Deaths: 1/589

Serious adverse events (2 terms)

Reaction	System	CTA/CT-FFR Care Group	Routine Clinically-indicat…
Revascularization after 90 days	Cardiac disorders	—	—
Nonfatal myocardiol infraction	Cardiac disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	CTA/CT-FFR Care Group	Routine Clinically-indicat…
Hospitalization for unstable angina	Cardiac disorders	—	—

Most-reported serious reactions: Revascularization after 90 days, Nonfatal myocardiol infraction.

Data from ClinicalTrials.gov NCT03901326 adverse events section.

Sponsor's own description

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)

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. On-Site Computed Tomography-Derived Fractional Flow Reserve to Guide Management of Patients With Stable Coronary Artery Disease: The TARGET Randomized Trial.
   Yang J, Shan D, Wang X, Sun X, et al · · 2023 · cited 65× · PMID 36870065 · DOI 10.1161/circulationaha.123.063996
2. The effect of on-site CT-derived fractional flow reserve on the management of decision making for patients with stable chest pain (TARGET trial): objective, rationale, and design.
   Yang J, Shan D, Dong M, Wang Z, et al · · 2020 · cited 10× · PMID 32819429 · DOI 10.1186/s13063-020-04649-9
3. The Effect of On-site CT-derived Fractional Flow Reserve on the Management of Decision Making for Patients with Stable Chest Pain (TARGET Trial): Objective, Rationale and Design
   yang j, shan d, wang z, dong m, et al · · 2020 · DOI 10.21203/rs.2.21500/v3