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Coronary Artery Disease Progression in Patients With Prediabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02744976
Recruitment Status : Active, not recruiting
First Posted : April 20, 2016
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Karlis Trusinskis, Pauls Stradins Clinical University Hospital

Brief Summary:

Prediabetes is a disorder of glucose metabolism that reflects the natural history of progression from normoglycaemia to type 2 diabetes mellitus. Patients with prediabetes have impaired glucose regulation caused by insulin resistance (IR). IR in patients undergoing percutaneous coronary intervention (PCI) is associated with coronary artery remodeling and coronary plaque vulnerability by intravascular ultrasound (IVUS) analysis. In stent restenosis after bare metal and drug-eluting stent implantation more frequently is observed in patients with high fasting-insulin levels and IR. Although IR has a significant role in the progression of atherosclerosis in prediabetic patients, the importance of managing prediabetes is often under-appreciated by clinicians. To date, no pharmacological treatment has been officially approved for prediabetes. According to American Diabetes Association recommendations, metformin is the only drug that could be considered in the treatment of prediabetic patients with a high risk of developing diabetes. Metformin is a safe and inexpensive glucose lowering drug that attenuates mortality and future cardiovascular events in patients with type 2 diabetes as well as the progression of atherosclerosis in non-diabetic animal models. This study was designed to analyze coronary plaque characteristics by iMAP IVUS in patients with and without prediabetes undergoing PCI and to evaluate the impact of metformin treatment on coronary plaque characteristics in prediabetic patients at 24 month follow up.

The study hypothesis is that more pronounced coronary atherosclerosis progression as well as in-stent neointimal hyperplasia will be observed in patients with prediabetes. Metformin treatment attenuates the progression of atherosclerosis in patients with prediabetes.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Atherosclerosis Prediabetic State Drug: Metformin Behavioral: Lifestyle recommendations Phase 4

Detailed Description:
Patients undergoing PCI and IVUS pullback for the target vessel will be enrolled in a prospective study. Before PCI and at 24 month follow up fasting blood will be collected for glucose, HbA1c, C peptide, lipid profile assessment. Patients' baseline demographic characteristics, medical history, and procedural data will be collected during the index hospitalization and at 24 month follow up. Patients will be divided in groups according to HbA1c - control group (HbA1c<5.7) and prediabetic patients (HbA1c 5.7-6.4). PCI will be performed in accordance with the guidelines. After successful treatment of the culprit lesion IVUS will be done. Following PCI and IVUS patients with prediabetes will be randomly assigned in groups either receiving metformin at a dose of 2000 mg once daily plus standard lifestyle recommendations or standard lifestyle recommendations only. Intravascular ultrasound analysis will be repeated 24 months after the initial PCI.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coronary Artery Disease Progression by iMap Intravascular Ultrasound Analysis in Patients With Prediabetes
Study Start Date : February 2016
Actual Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prediabetes, metformin
Patients with HbA1c 5.7-6.4 receiving metformin and lifestyle recommendations
Drug: Metformin
In order to minimize gastrointestinal discomfort, metformin treatment will be started with a dose of 500 mg p/o once daily, then gradually increased to 2000 mg p/o once daily for 24 months
Other Name: Glucophage extended release (XR)

Behavioral: Lifestyle recommendations
Standard lifestyle recommendations

Active Comparator: Prediabetes, lifestyle
Patients with HbA1c 5.7-6.4 receiving lifestyle recommendations
Behavioral: Lifestyle recommendations
Standard lifestyle recommendations




Primary Outcome Measures :
  1. Percentage plaque volume change over 24 months [ Time Frame: 24 months ]
    Changes in plaque volume in 24 months


Secondary Outcome Measures :
  1. Culprit lesion in-stent restenosis [ Time Frame: 24 months ]
    Neointimal hyperplasia at 24 month follow up

  2. Plaque tissue component percentage change over 24 months [ Time Frame: 24 months ]
    Percentage change in necrotic, fibrotic, lipidic and calcific tissue volume

  3. Correlation of glycemic parameters with plaque characteristics [ Time Frame: At index hospitalization and follow up (24 months) ]
    Correlation of glycemic parameters with plaque characteristics

  4. Plaque volume change in metformin vs non-metformin treated patients over 24 months [ Time Frame: 24 months ]
    Plaque volume change in metformin vs non-metformin treated patients over 24 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥18 and <75 years;
  • patients with stable coronary artery disease referred to PCI in an artery suitable for IVUS pullback;
  • signed informed consent before PCI.

Exclusion Criteria:

  • cardiac or non-cardiac illness with life expectancy of less than two years;
  • failure to advance the IVUS catheter through the culprit lesion;
  • acute coronary syndrome
  • congestive heart failure (New York Heart Association (NYHA) classification stage III-IV)
  • diabetes mellitus
  • chronic kidney disease
  • previous PCI in the target vessel
  • heavily calcified vessels
  • allergy to metformin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744976


Locations
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Latvia
Pauls Stradins Clinical University hospital
Riga, Latvia
Sponsors and Collaborators
Pauls Stradins Clinical University Hospital
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Responsible Party: Karlis Trusinskis, MD, PhD, Pauls Stradins Clinical University Hospital
ClinicalTrials.gov Identifier: NCT02744976    
Other Study ID Numbers: IVUS-0216
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Karlis Trusinskis, Pauls Stradins Clinical University Hospital:
Coronary artery disease
Atherosclerosis
Prediabetes
Intravascular ultrasound
Insulin resistance
Percutaneous coronary intervention
Metformin
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Prediabetic State
Glucose Intolerance
Disease Progression
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs