Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ

Status Recruiting

Clinical Trial Summary

Disorders of glycemic regulation are common in patients hospitalized for acute coronary syndrome (ACS). Abnormal glycaemia is observed in 50% of cases, in 30-40% diabetes, and in 25-35% fasting hyperglycaemia or glucose intolerance. Hyperglycemia is a major prognostic factor in ACS, with admission hyperglycemia having independent prognostic value for both short- and long-term major cardiovascular events (MACE), regardless of the presence of diabetes. Metabolically, several situations can be distinguished: - Hyperglycaemia occurs in known non-diabetic ACS subjects. It can be indicative of (i) Type 2 Diabetes or (ii) stress hyperglycaemia (diagnostic threshold for blood sugar varies according to learned societies, with HbA1c < 6.5%). - Hyperglycaemia occurs in known diabetic ACS subjects Most studies use admission blood sugar as a predictor. However, it has recently been shown that glycemic variability indexes would be better predictors of MACE. Using continuous glucose measurement for 48 h, it has been shown that significant glycemic variability is a more powerful predictor of MACE at 1 year than admission glycemia The measurement of glycemic variability is mainly possible thanks to the development of CGM (continuous glucose measurement). To our knowledge, no study has been interested in evaluating the predictive value of the various glycemic parameters measured by CGM. Published studies have used continuous glucose measurements for very short periods (24 or 72 hours maximum), which limits these measurements. The freestyle libre Pro iQ (FSLPro iQ) is a professional sensor for continuous, non-invasive interstitial glucose measurement allowing the recording of glycemic parameters for 2 weeks. Our hypothesis is that glycaemic parameters, alone or in combination with each other or with other patient risk factors, measured with the Freestyle libre Pro iQ have a significant prognostic value in terms of cardiovascular clinical events at 12 months in a population of patients with ACS managed as standard and followed up.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06014112
Study type	Interventional
Source	University Hospital, Montpellier
Contact	Ariane SULTAN, Professor
Phone	0467338431
Email	a-sultan@chu-montpellier.fr
Status	Recruiting
Phase	N/A
Start date	November 6, 2023
Completion date	May 6, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06013813` - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI	N/A
Recruiting	`NCT05846893` - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease	N/A
Recruiting	`NCT05412927` - AngelMed Guardian® System PMA Post Approval Study
Completed	`NCT02750579` - Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes?	N/A
Completed	`NCT04102410` - Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients	N/A
Enrolling by invitation	`NCT03342131` - Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome	N/A
Recruiting	`NCT01218776` - International Survey of Acute Coronary Syndromes in Transitional Countries
Enrolling by invitation	`NCT04676100` - International CR Registry
Completed	`NCT03590535` - 5th Generation cTnT in ED ACS
Recruiting	`NCT05437900` - INSIGHTFUL-FFR Clinical Trial	Phase 4
Completed	`NCT05551429` - Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
Terminated	`NCT04316481` - IDE-ALERTS Continued Access Study	N/A
Active, not recruiting	`NCT04475380` - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting	`NCT04852146` - Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.
Active, not recruiting	`NCT02892903` - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes?	N/A
Completed	`NCT04077229` - Piloting Text Messages to Promote Positive Affect and Physical Activity	N/A
Not yet recruiting	`NCT02871622` - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM	N/A
Completed	`NCT02944123` - Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR)	Phase 3
Active, not recruiting	`NCT02922140` - The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit	N/A
Terminated	`NCT02620202` - Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS — FREESCA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms