A Randomized, Open label, Comparative clinical trial to determine the Efficacy and Safety of Ischemia Reversal Program (IRP) along with diet modification as an add-on therapy to conventional treatment versus conventional treatment alone on plaque volume of Coronary Artery Disease (CAD) patients.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean change in Mean Plaque volume using IVUS guided angiography
研究概览
简要总结
This is a randomized, open label comparative clinicaltrial to determine the Efficacy and Safety of Ischemia Reversal Program (IRP)along with diet modification as an add-on therapy to conventional treatmentversus conventional treatment alone on plaque volume of Coronary Artery Disease(CAD) patients.
Theprimary endpoint of the study is to determine the reduction in mean plaquevolume of CAD patients at the end of 120 days using Intravascular Ultrasound(IVUS) guided angiography.
Thesecondary endpoints of the study are as follows: 1. Determination of reductionin maximum atheroma area 2. Determination of reduction in EEM (External ElasticMembrane) area 3. Evaluation of improvement in Apo A1 4. Evaluation ofreduction in Apo B 5. Determination of reduction in summed difference score in MyocardialPerfusion Imaging (MPI)/SPECT tests
Also, safety will be assessed based onfrequency, severity and intensity of adverse events (AEs) and changes in thelaboratory values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects between 40 to 75 years of age.
- •Subjects with known case of significant Coronary Artery Disease (CAD) with soft plaque as detected by Intravascular Ultrasound (IVUS) guided angiography.
- •Subjects with known case of CAD with stable dose of standard therapy for at least 3 months.
- •4.Subjects with BMI in the range of 26 to 30 kg/m
- •5.Subjects with known case of Type 2 Diabetes Mellitus with HbA1c value between 7% to 8% (on regular and stable medication from last 3 months).
- •Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Subject with severe Calcified plaque or no plaque as detected by Intravascular Ultrasound (IVUS) guided angiography.
- •Subjects with history of Coronary artery bypass grafting (CABG).
- •Subjects with known case of symptomatic CAD (Chest pain at Rest).
- •Subjects with recent acute coronary syndrome (within last 3 months).
- •Subjects with acute heart failure (within 24 hrs).
- •Subjects with Irritable bowel syndrome.
- •Subjects with clinically diagnosed bleeding piles or prolapsed or fistula (grade I or II piles).
- •Subjects with Hemorrhoids (2nd or 3rd degree).
- •Subject with known case of Asthma or COPD.
- •Subjects with known case of Cancer.
- •Subjects with physical disability in any form leading to immobilization.
- •Subjects with Anemia (Hemoglobin less than 10 gm/dL).
- •Subjects with hepatic or renal insufficiency.
- •Subjects with suspected inability or unwillingness to comply with the study procedures.
- •Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •Suspected inability or unwillingness to comply with the study procedures.
- •Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Females who are not ready to use acceptable contraceptive methods during the course of study.
结局指标
主要结局
Mean change in Mean Plaque volume using IVUS guided angiography
时间窗: Reduction in mean Plaque volume from baseline to end of study visit (120 days).
次要结局
- Mean change from baseline in maximum atheroma area in IVUS guided angiography(Reduction in atheroma area in IVUS guided angiography from baseline to the end of study visit (120 days))
- Mean change in external elastic membrane (EEM)(Reduction in external elastic membrane from baseline to end of study visit (120 days))
- Mean change in Apo A1(Improvement in Apo A1 from baseline to end of study visit (120 days))
- Mean change in Apo B(Reduction of Apo B from baseline to end of study visit (120 days))
- Mean change in Summed difference score in Myocardial perfusion imaging(Reduction in summed difference score in Myocardial perfusion imaging from baseline to end of study visit (120 days))