Early MRI Detection of Myocardial Deterioration as a Preventive, Disease Staging, and Prognostic Biomarker in Insulin Resistance
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|ClinicalTrials.gov Identifier: NCT03509441|
Recruitment Status : Unknown
Verified April 2018 by Rajesh Dash, MD PHD, Stanford University.
Recruitment status was: Recruiting
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
|Condition or disease|
|Cardiomyopathies Insulin Resistance Non-ischemic Cardiomyopathy Cardiac Fibrosis Diabetes|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Early MRI Detection of Myocardial Deterioration as a Preventive, Disease Staging, and Prognostic Biomarker in Insulin Resistance|
|Actual Study Start Date :||January 15, 2015|
|Estimated Primary Completion Date :||November 11, 2019|
|Estimated Study Completion Date :||November 11, 2019|
South Asians with Insulin Resistance
125 patients (anticipated)
South Asians without Insulin Resistance
125 patients (anticipated)
- Identifying patients with high fibrosis levels using peripheral blood samples [ Time Frame: Blood samples drawn once at baseline visit ]
The investigators will collect and store peripheral blood samples from every patient, identify those with high and low fibrosis levels using our described protocol, and then select patients with disproportionately high fibrosis levels given their disease burden.
The investigators can test for the level of fibrosis by generating induced pluripotent stem cell-derived cardiomyocytes (iPSC- CMs) from these collected blood samples. These iPSC-CMs will be tested, in vitro, for drug sensitivity, susceptibility to apoptotic stimuli, and the propensity to produce pro-fibrotic cytokine activation- all factors which will help the investigators determine fibrosis levels.
- Insulin Sensitivity measured by OGTT [ Time Frame: OGTT done at baseline/ first visit ]An oral glucose tolerance test with insulin measurement (OGTT) will be performed for all the patients. The investigators will draw blood to determine a fasting glucose measurement, and then the patients will be given a 75 g glucose solution to drink. Blood samples will be collected at serial time points (30 minutes, 60 minutes, 120 minutes) after ingestion of this liquid to determine blood glucose and insulin levels. The OGTT will help investigators determine the patient's degree of insulin sensitivity.
- Insulin Sensitivity measured by Fasting Lipid Panel [ Time Frame: Lipid Panel done at baseline/ first visit ]Baseline fasting lipids will be assessed to calculate a TG/HDL-C ratio, which also correlates with the degree of insulin sensitivity or lack thereof. These results will be correlated to the insulin sensitivity assessment performed by the OGTT.
- Left ventricular volume [ Time Frame: CMR done at baseline visit ]Cardiac MRI/ CMR done to noninvasively image heart and determine volume of left ventricle
- Left ventricular mass [ Time Frame: CMR done at baseline visit ]Cardiac MRI/ CMR done to noninvasively image heart and determine mass of left ventricle
- Ejection fraction % [ Time Frame: CMR done at baseline visit ]Cardiac MRI/ CMR done to noninvasively image heart and determine ejection fraction
- Myocardial tagging for strain analysis [ Time Frame: CMR done at baseline visit ]Cardiac MRI/ CMR done to noninvasively image heart and assess ventricular function through myocardial tagging. By modulating the magnetization gradient of the MRI prior to acquiring images, any parts of the heart which are not contracting can be identified. These images will be analyzed via strain analysis for such abnormalities in function
- Assessing diffuse fibrosis via T1 mapping [ Time Frame: CMR done at baseline visit ]A CMR technique called T1 mapping will be performed to calculate level of extracellular volume (ECV), which helps with the quantification of diffuse fibrosis
- Assessing level of edema via T2 mapping [ Time Frame: CMR done at baseline visit ]A CMR technique called T1 mapping will be performed assess amount of edema in the heart
- Collagen turnover assessment [ Time Frame: Blood drawn at baseline visit ]Patients will have blood drawn for serum measurement of propeptides of several procollagens to determine the level of collagen turnover
- Endothelial Function [ Time Frame: 15 minute procedure done at baseline visit ]The investigators will also measure endothelial function using the endoPAT device, which employs noninvasive measurement of finger arterial pulsatile volume changes as a measure of endothelial function. This test takes approximately 15 minutes and is noninvasive.
- Urine test for albumin levels [ Time Frame: One urine test done at baseline visit ]24 Hour urine test for assessment of albumin levels
- Urine test for creatinine levels [ Time Frame: One urine test done at baseline visit ]24 Hour urine test for assessment of creatinine levels
Biospecimen Retention: Samples With DNA
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): NCT03509441
|Contact: Esha Roy, BSfirstname.lastname@example.org|
|Contact: Rajesh Dash, MD, PhDemail@example.com|
|Principal Investigator:||Rajesh Dash, MD, PhD||Stanford University|
|Study Director:||Abha Khandelwal, MD||Stanford University|