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NCT03045601
Diagnostic Accuracy of CT-FFR Compared to Invasive Coronar Angiography With Fractional Flow Reserve
NA trial testing CT-FFR in Coronary Disease in 182 participants. Completed in 1 March 2021.
1 March 2021
Quick facts
| Lead sponsor | St. Olavs Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 182 |
| Start date | 21 February 2017 |
| Primary completion | 1 March 2021 |
| Estimated completion | 1 March 2021 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- CT-FFR
- Stress echocardiography
Conditions studied
- Coronary Disease — all drugs for Coronary Disease →
Sponsor
St. Olavs Hospital
Who can join
Adults 18 to 75, any sex, with Coronary Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Invasive coronary angiography is currently considered gold standard in the assessment of coronary artery disease although the method has limitations. Most importantly invasive angiography only depicts coronary anatomy without determining its physiological significance i.e the likelihood that the stenosis impedes oxygen delivery to the heart muscle. Fractional flow reserve (FFR) is a catheterization technique for assessing the physiological significance of a coronary artery lesion during invasive coronary angiography. Coronary computed tomographic angiography (CCTA) is a noninvasive imaging test that has become an alternative route to diagnosis for patients with suspected coronary artery disease. Computational fluid dynamics combined with anatomical models based on CCTA scans allows determination of coronary flow and pressure, and has emerged as a promising diagnostic modality called CT-FFR. In this Project New Mathematical algorithms are developed for computation of CT-FFR. The main objective of this study is to determine the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve and state-of-the-art dobutamin stress echocardiography.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Dobutamine stress echocardiography after positive CCTA: diagnostic performance using fractional flow reserve and instantaneous wave-free ratio as reference standards.
Tjellaug Bråten A, Holte E, Wiseth R, Aakhus S. · · 2024 · cited 3× · PMID 39349050 · DOI 10.1136/openhrt-2024-002899 -
Automated computed tomography-derived fractional flow reserve model for diagnosing haemodynamically significant coronary artery disease: a prospective validation study.
Bråten AT, Fossan FE, Muller LO, Jørgensen A, et al · · 2024 · cited 2× · PMID 39450294 · DOI 10.1093/ehjimp/qyae102
Verify or expand the search:
- PubMed search for NCT03045601
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CT-FFR
Trials testing the same drug.
- NCT05611190 — CT-FFR-guided Strategy for In-stent Restenosis · NA · unknown
- NCT05593120 — Evaluation of Health Economics for Noninvasive Coronary Fractional Flow Reserve Measurement Technology · unknown
- NCT06153927 — Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve · completed
- NCT04939207 — Safety and Cost-efficiëncy of New Imaging Techniques in Patients Suspected of Coronary Artery Disease · NA · recruiting
- NCT04664439 — Follow-up With CT-FFR in CHD Patients After DCB · NA · unknown
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Other St. Olavs Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03045601 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St. Olavs Hospital
- Last refreshed: 9 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03045601.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing