Trial · NCT07891988
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Renal Function: Log Serum Creatinine | 2, 30, and 90 days after endovascular revascularisation | Assessment of short and medium-term renal decline by measuring serum creatinine from blood samples processed at local pathology laboratories. Unit of Measure: log(µmol/L). Renal decline or "worsening of kidney function" is defined as a \>25% decline in the estimated Glomerular Filtration Rate (eGFR) from the baseline assessment. The baseline eGFR is defined as the most recent value recorded prior to the procedure. Additionally, the trial measures short and medium-term renal decline by tracking changes in Log serum creatinine at 2, 30, and 90 days post-procedure, and evaluates the onset of Acute Kidney Injury (AKI) based on the KDIGO criteria. |
| Secondary | Volume of iodinated contrast medium used | Intraoperative (during the index procedure) | Measurement of the overall volume of iodinated contrast medium required to complete the endovascular revascularisation procedure. Unit of Measure: Milliliters (ml) |
| Secondary | Incidence of Acute Kidney Injury (AKI) | Within 2 days (48 hours) of the procedure | Assessment of the development of acute kidney injury evaluated using the Kidney Disease Improving Global Outcomes (KDIGO) criteria. Unit of Measure: Percentage (%) of participants |
| Secondary | Proportion of participants developing Major Adverse Kidney Events (MAKE) | By 90 day post index procedure follow-up | The development of a major adverse kidney event, defined as either death, new requirement for dialysis, or worsening kidney function indicated by a \>25% decline in estimated Glomerular Filtration Rate (eGFR) from baseline. Unit of Measure: Percentage (%) of participants |
| Secondary | Inpatient stay duration | By 90 day post index procedure follow-up | The length of time the participant spent as an inpatient since randomisation. Unit of Measure: Days |
| Secondary | Pain experienced during the procedure | During the index procedure (measured at the first and final angiogram) | Assessment of the pain experienced by the participant during the injection of the contrast medium, measured using a Visual Analogue Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Unit of Measure: Score on a scale from 0 to 10 |
| Secondary | Quality of Life: EQ-5D-5L | Baseline and 90 days post-procedure | Assessment of health-related quality of life measured using the EuroQOL 5D 5L (EQ-5D-5L) Questionnaire. It assesses 5 dimensions on a 1-5 scale and includes a visual analogue scale rating current health from 0 (worst) to 100 (best). Unit of Measure: Score on a scale from 0 to 100 |
| Secondary | Quality of Life: SF-36 | Time Frame: Baseline and 90 days post-procedure | Assessment of health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36) Questionnaire, which covers eight domains of health converted into a total score indicating low to high quality of life. Unit of Measure: Total score |
| Secondary | Planned Revascularisation Completion Rate | Intraoperative (during the index procedure) | Evaluation of the technical success of the intervention by calculating the proportion of endovascular revascularisation procedures that were completed as originally planned. Unit of Measure: Percentage (%) of participants |
| Secondary | Number of Re-interventions | By 90 day post index procedure follow-up | Tracking the total number of subsequent surgical or endovascular re-interventions required. Unit of Measure: Number of interventions |
| Secondary | Participant Intervention Acceptability | By 90 day post index procedure follow-up | Evaluation of the acceptability of receiving carbon dioxide via the automated injector, assessed using a self-reported 8-item Theoretical Framework of Acceptability (TFA) Questionnaire. Higher scores indicate a higher level of acceptability. Unit of Measure: Score from 8 to 40 |
| Secondary | Procedure Associated Costs | By 90 day post index procedure follow-up | A micro-costing health economic analysis calculating the costs associated with the procedure, including equipment, staff, hospital stays, and community services. Cost in Great British Pounds (£) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT07891988/registered