Coronary Artery Disease Clinical Trial
Official title:
Pilot Trial Studying the Effects of Pioglitazone in Comparison to Placebo on Myocardial Function and Oxidative Stress in Patients With Type II Diabetes and Insulin Resistance Undergoing Elective PTCA. A Randomized Double-blinded Phase II Study.
The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on heart functioning before, during and after stent implantation.
Type 2 diabetes increases the risk of coronary heart disease at least by two to three fold
compared with non-diabetic subjects. Moreover, prospective studies have shown a significant
correlation between several glycemic confounders and morbidity from coronary heart disease
even in patients without diabetes mellitus. In patients with previously diagnosed coronary
heart disease, impaired glucose tolerance was found in 30 to 67 %. The cardiovascular risk
of patients with insulin resistance, with or without glucose intolerance has become more and
more apparent within recent years and quantitative coronary angiographic studies have
revealed a correlation between the severity of coronary heart disease and impaired glucose
tolerance.
A new pharmaceutical class for the intervention of insulin resistance, the peroxisome
proliferator activated receptor (gamma) agonists have been successfully introduced in the
treatment of type 2 diabetes. Beyond their metabolic effects on glucose and lipid
metabolism, peroxisome proliferator activated receptor (gamma) agonists show to exert a
couple of pleiotropic, anti-inflammatory and vasoprotective effects in patients with type 2
diabetes and impaired glucose tolerance.
The incidence and severity of peri-procedural myocardial injury during percutaneous coronary
interventions with stent implantation in diabetic and in non-diabetic patients is an
important prognostic confounder for the patient. Different laboratory biomarkers have been
investigated as diagnostic tools for the estimation of the risk of peri-procedural
myocardial injury. Recent studies have convincingly demonstrated that the risk of subsequent
ischemic heart events is related to the extent of cardiac troponin or CK-MB increase after
coronary intervention, and the prognosis for these individuals is usually worse than that
for patients who do not develop an increase in these biomarkers.
In a recent trial it was shown that pretreatment with atorvastatin could reduce procedural
myocardial injury in elective coronary intervention. The incidence of Troponin I increase
was 48% in the placebo group compared to 20% in the atorvastatin group.
The aim of this study is to investigate the effect of pioglitazone on the incidence of
peri-procedural myocardial injury in patients undergoing percutaneous coronary interventions
with stent implantation. Total participation time is anticipated to be 3 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
| Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
| Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
| Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
| Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
| Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
| Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
| Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
| Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
| Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
| Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
| Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
| Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
| Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
| Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
| Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
| Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
| Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
| Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
| Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |