Clinical Trials Logo

Clinical Trial Summary

The investigators will collect prospectively baseline, procedural and follow-up data of all patients receiving successful percutaneous coronary intervention (PCI) and stent implantation. Angio-based flow fractional reserve (quantitative flow ratio, QFR, Medis medical imaging systems Leiden, The Netherlands) will be estimated in all patients. Especially, the investigators at the end of the procedure (this is defined according operator's judgement) will record 2 orthogonal angiograms (as suggested by QFR instructions) at 15 frames/second and the same 2 orthogonal angiograms at 30 frames/second. An independent corelab (blinded to procedural data and clinical outcome) will estimate QFR value (one with the angiograms at 15 frames and one with those at 30 frames


Clinical Trial Description

Fractional flow reserve (FFR) allows to evaluate the functional significance of coronary artery lesions, through the ratio of the mean coronary artery pressure after the stenosis to the mean aortic pressure during maximum hyperaemia. The actual widely accepted cutoff value is 0.80. Below this value, an intermediate coronary lesion is considered significant and its treatment with percutaneous coronary intervention (PCI) is justified. The measurement FFR after stent implantation has a strong predictive value with respect to death, myocardial infarction, or need for repeat revascularization of the target vessel within 6 months. The higher the FFR, the lower the event rate. FFR cut-off of 0.90 might be a useful indicator in daily practice for optimal physiologic stent implantation. Nevertheless, the use of the FFR in the post stenting , is relatively low, because of costs of the pressure wire and the adverse effects related to the use of adenosine. A new method (QFR by Medis medical imaging) for evaluation of the functional significance of coronary stenosis is based on computer calculation of the FFR value. This calculation is performed by analysing the coronary angiogram and thus reduces or potentially eliminates the need for measuring FFR by pressure wires. The QFR method combines a 3D reconstructions of the target vessel based on two angiographic projections and the contrast flow velocity to compute the "FFR value". To perform QFR the investigators will acquire two angiographic projections with angle >25 degree that allow the 3D reconstruction of the vessel (see values below). Projections for left main (LM) and proximal left anterior descending (LAD) or proximal left circumflex (LCX): right anterior oblique (RAO) 20, Caudal 45 and anterior-posterior (AP), Caudal 10 Projections for LAD/diagonal: AP, Cranial 45 and RAO 35, Cranial 20 Projections for LCX/obtuse marginal (OM): left anterior oblique (LAO) 10, Caudal 45 and RAO 25, Caudal 25 Projections for Proximal+Mid right coronary artery (RCA): LAO 45, caudal (CAUD) 0 and AP, CAUD 0 Projections for postero-lateral artery and posterior-descending artery (PLA/PDA): LAO 45, CAUD 0 and LAO 30, CAUD 30 Finally, the investigators will assess the relationship between QFR value and adverse events. We will assess the best QFR value able to discriminate the cumulative occurrence of adverse events. In the study, we will include also ST-segment elevation myocardial infarction patients. This subset of patients will be analysed as independent cohort to obtain preliminary results and will be analysed in a independent study ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02811796
Study type Observational
Source University Hospital of Ferrara
Contact
Status Completed
Phase
Start date June 2016
Completion date April 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04101448 - Prevalence of Bronchiectasis in COPD Patients
Recruiting NCT03635619 - The Application of 3T MRI in Esophageal Cancer
Recruiting NCT04377854 - Prognostic Value of BNP in MCS - a 25 Year Follow up Study
Completed NCT05586828 - A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.
Enrolling by invitation NCT04517981 - Cohort Study on the Outcome and Influencing Factors of Perinatal Depression
Recruiting NCT05229328 - Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Sepsis
Completed NCT04470440 - Thyroid Dysfunction and Nivolumab Reponse in NSCLC
Recruiting NCT05848310 - Preoperative Serum FGF19 in the Prognosis of Biliary Atresia
Completed NCT02582333 - Clinical Course Study in Chronic Hepatitis B After Nucleos(t)Ide Analogue Therapy
Completed NCT03652402 - Precision Risk Stratification in Kidney Transplant Patients - EU-TRAIN
Recruiting NCT04651933 - A Training Set for the HRD Model in EOC
Completed NCT04651920 - A Study on Association Between HR Genes and the HRD Status in Chinese Epithelial Ovarian Cancer
Recruiting NCT03843905 - Predictive Value of Innovative Prognostic Markers (Gut Microbiota, Sarcopenia, Metabolic Syndrome and Obesity) on Surgical and Oncologic Results in the Management of Sporadic Colorectal Adenocarcinoma.
Completed NCT05620537 - A Novel Nomogram to Predict the Postoperative Overall Survival in Gastrointestinal Cancer Patients
Recruiting NCT03742869 - HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma
Recruiting NCT03738319 - Non-coding RNA in the Exosome of the Epithelia Ovarian Cancer
Completed NCT03268096 - Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination
Recruiting NCT04004559 - MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02)
Recruiting NCT05494502 - Impact of Erector Spinae Plane Block on Chronic Postsurgical Pain in Breast Cancer Patients N/A
Recruiting NCT04411563 - Epigenetic Tools as Prognostic Predictors in Covid19