CompletedPhase 2/3

Impact of Diabetes on Left Ventricular Remodeling

United States72 participantsStarted 2005-07

Plain-language summary

The investigators hypothesize that in patients with diabetes and acute myocardial infarction (MI), Ang II type-1 receptor blockade (AT1RB) attenuates left ventricle (LV) remodeling to a greater extent than angiotensin converting enzyme (ACE) inhibitor therapy and that the addition of xanthine oxidase (XO) inhibitor, Allopurinol, results in further improvement in LV remodeling and function in the follow-up phase after MI.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 21 years old or older
. MI documented by increase in troponin \> 0.78 ng/ml or CKMB ≥ 3% of total CK
. Confirmed (i.e., two or more readings) fasting blood glucose \>126mg/dl; or
. Random glucose ≥200mg/dl; or
. 2 hour glucose ≥200mg/dl following 75g of glucose; or
. Current treatment with diet or oral agents directed at the control of hyperglycemia either alone or in combination with insulin; or
. Current treatment with insulin with no prior history of diabetic ketoacidosis.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)

Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)

Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)

Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular Ejection Fraction (LVEF)

Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)

Timeframe: 5 visits per Participant over 2 years (about every 6 months)

LV End Systolic Maximum Shortening (LVES Max Shortening)

Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Trial details

NCT IDNCT01052272

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-11

Results submitted2012-03-20

View on ClinicalTrials.gov More Diabetes trials

Plain-language summary

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 21 years old or older
. MI documented by increase in troponin \> 0.78 ng/ml or CKMB ≥ 3% of total CK
. Confirmed (i.e., two or more readings) fasting blood glucose \>126mg/dl; or
. Random glucose ≥200mg/dl; or
. 2 hour glucose ≥200mg/dl following 75g of glucose; or
. Current treatment with diet or oral agents directed at the control of hyperglycemia either alone or in combination with insulin; or
. Current treatment with insulin with no prior history of diabetic ketoacidosis.

Exclusion criteria

What they're measuring

Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)

Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)

Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)

Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular Ejection Fraction (LVEF)

Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)

Timeframe: 5 visits per Participant over 2 years (about every 6 months)

LV End Systolic Maximum Shortening (LVES Max Shortening)

Timeframe: 5 visits per Participant over 2 years (about every 6 months)