Trial Outcomes & Findings for Cardiac CT's Role in Asymptomatic Patients With Diabetes and Metabolic Syndrome (NCT NCT01564485)

Results Overview

After randomization to either obtain cardiac CT or usual care, patients will be followed for 5 years (with assessment of outcomes at every 6 months) to see any difference in control of systolic blood pressure. The outcome with be assessed as a continuous measure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

193 participants

Primary outcome timeframe

Five year follow up

Results posted on

2021-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Cardiac CT Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries. Cardiac CT: A cardiac CT involves a non-invasive test of the coronary arteries.	Usual Care Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician Usual medical care: Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion.
Overall Study STARTED	92	101
Overall Study COMPLETED	84	78
Overall Study NOT COMPLETED	8	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cardiac CT's Role in Asymptomatic Patients With Diabetes and Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cardiac CT Group n=92 Participants Asymptomatic patients with Type II DM who received cardiac CT screening test	Usual Care Group n=101 Participants Asymptomatic patients with Type II DM who received usual care	Total n=193 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	85 Participants n=5 Participants	91 Participants n=7 Participants	176 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	58 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	43 Participants n=7 Participants	81 Participants n=5 Participants

PRIMARY outcome

Timeframe: Five year follow up

After randomization to either obtain cardiac CT or usual care, patients will be followed for 5 years (with assessment of outcomes at every 6 months) to see any difference in control of systolic blood pressure. The outcome with be assessed as a continuous measure.

Outcome measures

Outcome measures
Measure	Cardiac CT n=75 Participants Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries. Cardiac CT: A cardiac CT involves a non-invasive test of the coronary arteries.	Usual Care n=72 Participants Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician Usual medical care: Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion.
Systolic BP Pressure	145 mm Hg Standard Deviation 6	144 mm Hg Standard Deviation 5

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Medication dose change or medication start/stop

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Medication dose change or medication start/stop

Outcome measures

Outcome data not reported

Adverse Events

Cardiac CT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ashwini Erande, Clinical Coordinator

University of California, Irvine

Phone: 714 456 7025

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place