Trial Outcomes & Findings for Pathways to Cardiovascular Disease Prevention (DCRI Central and Statistical Coordinating Center) (NCT NCT04025125)
NCT ID: NCT04025125
Last Updated: 2025-08-01
Results Overview
A binary variable, with 'yes' defined if there is documented evidence that a ambulatory visit was made with a cardiologist after becoming eligible by CVD risk score, and 'no' otherwise. Patients were followed from the date when they met eligibility criteria to the date of first encounter with a cardiology specialist or through a maximum of 5 years from their eligibility date. Follow-up was censored early at the end of data collection (December 31, 2020), or 6 months after the patient's last ambulatory visit, if earlier.
COMPLETED
2039 participants
5 years
2025-08-01
Participant Flow
retrospective data study
As is pre-specified in the study protocol, Aim 3 data are not reported here.
Participant milestones
| Measure |
Overall
cohort who have new elevated Cardiovascular Disease (CVD) risk
|
|---|---|
|
Overall Study
STARTED
|
2039
|
|
Overall Study
COMPLETED
|
2039
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1001 participants had data or were eligible for ASCVD analysis scoring.
Baseline characteristics by cohort
| Measure |
Overall
n=2039 Participants
Overall cohort.
|
|---|---|
|
Age, Continuous
|
45 years
n=2039 Participants
|
|
Sex: Female, Male
Female
|
1061 Participants
n=2039 Participants
|
|
Sex: Female, Male
Male
|
978 Participants
n=2039 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
225 Participants
n=2039 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1810 Participants
n=2039 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=2039 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=2039 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=2039 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2039 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1755 Participants
n=2039 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=2039 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=2039 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
164 Participants
n=2039 Participants
|
|
Region of Enrollment
United States
|
2039 Participants
n=2039 Participants
|
|
Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score
|
5.1 10-year risk percentage
n=1001 Participants • 1001 participants had data or were eligible for ASCVD analysis scoring.
|
PRIMARY outcome
Timeframe: 5 yearsA binary variable, with 'yes' defined if there is documented evidence that a ambulatory visit was made with a cardiologist after becoming eligible by CVD risk score, and 'no' otherwise. Patients were followed from the date when they met eligibility criteria to the date of first encounter with a cardiology specialist or through a maximum of 5 years from their eligibility date. Follow-up was censored early at the end of data collection (December 31, 2020), or 6 months after the patient's last ambulatory visit, if earlier.
Outcome measures
| Measure |
Overall
n=2039 Participants
cohort who have new elevated CVD risk
|
|---|---|
|
Number of Participants With Visit to a Cardiology Specialist From Cohort
|
283 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsIncidence of all-cause death will be determined from electronic health record data and a query of the National Death Index.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsIncidence of first stroke event will be determined from diagnosis and/or procedure codes from electronic health record data.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsIncidence of first major adverse cardiovascular event (composite of cardiovascular death and myocardial infarction) will be determined from diagnosis and/or procedure codes from electronic health record data and a query of the National Death Index (Plus).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 60 minutesQualitative information will be assessed from semi-structured interviews conducted with participating healthcare providers
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 60 minutesQualitative information will be assessed from semi-structured interviews conducted with participating patients
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Longitudinal evaluation during 5 years of follow up.Cholesterol control will be defined based on prevailing guidelines during the study period and will be evaluated based on cholesterol laboratory measures recorded in electronic health record data.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Longitudinal evaluation during 5 years of follow up.Blood pressure control will be defined based on prevailing guidelines during the study period (blood pressure \<140/90 mmHg) and will be evaluated based on blood pressures recorded in electronic health record data.
Outcome measures
Outcome data not reported
Adverse Events
Overall
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place