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NCT04973410: FLOW3
The Association Between Catheter-based Coronary Flow and Resistance and 15O-H2O Positron Emission Tomography Scan
NA trial testing Coronary Physiology in Coronary Artery Disease in 40 participants. Completed in 1 July 2024.
31 December 2023
Quick facts
| Lead sponsor | Aarhus University Hospital Skejby |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 40 |
| Start date | 1 December 2019 |
| Primary completion | 31 December 2023 |
| Estimated completion | 1 July 2024 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Coronary Physiology
- 15O-H2O-PET scan
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
Aarhus University Hospital Skejby
Who can join
18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Aims 1. To assess the correlation between absolute flow and resistance assessed by catheter-based thermodilution technique using CoroFlow®-system and myocardial blood flow (MBF) measured by positron emission tomography (PET) and the tracer \[15O\] labeled water (\[15O\]H2O) (15O-H2O PET) 2. To assess the correlation between impaired MBF measured with 15O-H2O PET and negative fractional flow reserve (FFR) and index of microvascular resistance (IMR) level. Hypothesis: In patients with angina pectoris and reduced MBF measured with 15O-H2O PET but no hemodynamic significant stenosis (FFR \> 0.80), the IMR is \>25 measured with continuous thermodilution indicating microcirculatory dysfunction. Methods: We include patients with angina pectoris and suspected coronary disease based on a cardiac-computerised tomography (CT) scan. Patients are then referred to an 15O-H2O PET (rest and stress) and then a diagnostic invasive coronary angiography (ICA) with physiological assessment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04973410
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Aarhus University Hospital Skejby 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 NCT04973410 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aarhus University Hospital Skejby
- Last refreshed: 31 July 2024
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/NCT04973410.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing