Trial Outcomes & Findings for Visualization of Asymptomatic Atherosclerotic Disease for Optimum Cardiovascular Prevention (NCT NCT01849575)

NCT ID: NCT01849575

Last Updated: 2024-01-17

Results Overview

Framingham risk score. Composite gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual, based on levels of blood pressure, total cholesterol, LDL-cholesterol, systolic blood pressure, treatment for high blood pressure, diabetes, smoking and age. Minimum value=0, maximum value 100. Higher score means a worse outcome, i.e. a higher risk of cardiovascular diseases.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 3532 participants
• Primary outcome timeframe: one year
• Results posted on: 2024-01-17

Participant Flow

Information and collection informed consent: April 11 2012- June 1 2016 at the occasion of participation in the Västerbotten Intervention Program, Sweden, an ongoing CVD prevention program targeting residents at ages 40, 50 and 60 years Inclusion in the trial: April 29 2013-June 7 2016 at the Clinical research center, Umea University Hospital

Participant milestones

Measure	Intervention Intervention: Information about carotid ultrasound results to the participant and his/her primary care physician. Carotid intima-media thickness was presented as vascular age illustrating the individual's biological compared to chronological age, with a gauge going from green (at least 10 years younger), to yellow, orange or red (at least 10 years older). Plaque formation was a traffic light (green - no plaque, red - plaque). General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months. CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.	Control The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.
Overall Study STARTED	1749	1783
Overall Study COMPLETED	1599	1576
Overall Study NOT COMPLETED	150	207

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention n=1749 Participants Intervention: Pictorial information about carotid ultrasound results to the participant and his/her primary care physician. Asymptomatic atherosclerosis presented as vascular age with a gauge going from green (biological age 10 years younger than chronological age), over yellow, orange to red (10 years older). Plaque formation shown as a traffic light with a green dot (no plaque) or red dot (plaque) for each side. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months. CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.	Control n=1783 Participants The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.	Total n=3532 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1749 Participants	0 Participants n=1783 Participants	0 Participants n=3532 Participants
Age, Categorical Between 18 and 65 years	1749 Participants n=1749 Participants	1783 Participants n=1783 Participants	3532 Participants n=3532 Participants
Age, Categorical >=65 years	0 Participants n=1749 Participants	0 Participants n=1783 Participants	0 Participants n=3532 Participants
Sex: Female, Male Female	940 Participants n=1749 Participants	930 Participants n=1783 Participants	1870 Participants n=3532 Participants
Sex: Female, Male Male	809 Participants n=1749 Participants	853 Participants n=1783 Participants	1662 Participants n=3532 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	1749 participants n=1749 Participants	1783 participants n=1783 Participants	3532 participants n=3532 Participants
Framingham Risk Score	12.9 % risk of CVD within 10 years STANDARD_DEVIATION 9.6 • n=1749 Participants	12.8 % risk of CVD within 10 years STANDARD_DEVIATION 9.1 • n=1783 Participants	12.9 % risk of CVD within 10 years STANDARD_DEVIATION 9.3 • n=3532 Participants

PRIMARY outcome

Timeframe: one year

Framingham risk score. Composite gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual, based on levels of blood pressure, total cholesterol, LDL-cholesterol, systolic blood pressure, treatment for high blood pressure, diabetes, smoking and age. Minimum value=0, maximum value 100. Higher score means a worse outcome, i.e. a higher risk of cardiovascular diseases.

Outcome measures

Measure	Intervention n=1599 Participants The intervention: Giving communication about risk of cardiovascular disease in the form of written and graphical information about silent atheroscslerosis measured by carotid ultrasound examination as carotid intima-media thickness, highlighted as vascular age, and plaque formation, visualized as a traffic light (green - no plaque, red - plaque).The ultrasound results are given to the study person and his/her physician, in addition to information about conventional risk factors for cardiovascular disease Intervention: Information about carotid ultrasound results to the participant and his/her primary care physician in the form of atherosclerosis highlighted graphically in color against normal vascular age patterns and as plaque formation. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months. CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.	Control n=1576 Participants The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors
FRS	12.2 % risk of a CVD event within 10 years Interval 11.6 to 12.9	13.3 % risk of a CVD event within 10 years Interval 12.6 to 14.0

SECONDARY outcome

Timeframe: Follow-up after one year

SCORE: European systematic coronary risk evaluation. Risk of death (%) in myocardial infarction within 10 years expressed as statistical assessment based on smoking, systolic blood-pressure, blood cholesterol, age and sex.

SCORE is evaluated as a continuous variable with Minimum value=0%, maximum value=100%. Higher score means a worse outcome, i.e. a higher risk of cardiovascular diseases.

Outcome measures

Measure	Intervention n=1749 Participants The intervention: Giving communication about risk of cardiovascular disease in the form of written and graphical information about silent atheroscslerosis measured by carotid ultrasound examination as carotid intima-media thickness, highlighted as vascular age, and plaque formation, visualized as a traffic light (green - no plaque, red - plaque).The ultrasound results are given to the study person and his/her physician, in addition to information about conventional risk factors for cardiovascular disease Intervention: Information about carotid ultrasound results to the participant and his/her primary care physician in the form of atherosclerosis highlighted graphically in color against normal vascular age patterns and as plaque formation. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months. CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.	Control n=1783 Participants The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors
SCORE	1.42 % risk of a CVD event within 10 years Interval 1.33 to 1.55	1.58 % risk of a CVD event within 10 years Interval 1.47 to 1.68

SECONDARY outcome

Timeframe: 10 years

Data will be collected from the In-patient registry at the National Board of Health and Welfare.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 years

Data will be collected from the Causes of Deaths registry at the National Board of Health and Welfare.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 years

Data will be collected from computerized medical records from hospital care in the county, regional quality registry on myocardial infarctions and from the In-patient registry at the National Board of Health and Welfare.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years after baseline

Population: All participants who completed the carotid ultrasound examination at the 3-year follow-up

Carotid intima media thickness

Outcome measures

Measure	Intervention n=1575 Participants The intervention: Giving communication about risk of cardiovascular disease in the form of written and graphical information about silent atheroscslerosis measured by carotid ultrasound examination as carotid intima-media thickness, highlighted as vascular age, and plaque formation, visualized as a traffic light (green - no plaque, red - plaque).The ultrasound results are given to the study person and his/her physician, in addition to information about conventional risk factors for cardiovascular disease Intervention: Information about carotid ultrasound results to the participant and his/her primary care physician in the form of atherosclerosis highlighted graphically in color against normal vascular age patterns and as plaque formation. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months. CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.	Control n=1579 Participants The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors
Carotid Atherosclerosis	0.680 mm Standard Deviation 0.151	0.685 mm Standard Deviation 0.165

OTHER_PRE_SPECIFIED outcome

Timeframe: Follow-up after three years during September 5 2016 - May 28 2019

FRS=Framingham risk score. Composite gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual, based on levels of blood pressure, total cholesterol, LDL-cholesterol, systolic blood pressure, treatment for high blood pressure, diabetes, smoking and age. Minimum value=0, maximum value 100. Higher score means a worse outcome, i.e. a higher risk of cardiovascular diseases.

Outcome measures

Measure	Intervention n=1580 Participants The intervention: Giving communication about risk of cardiovascular disease in the form of written and graphical information about silent atheroscslerosis measured by carotid ultrasound examination as carotid intima-media thickness, highlighted as vascular age, and plaque formation, visualized as a traffic light (green - no plaque, red - plaque).The ultrasound results are given to the study person and his/her physician, in addition to information about conventional risk factors for cardiovascular disease Intervention: Information about carotid ultrasound results to the participant and his/her primary care physician in the form of atherosclerosis highlighted graphically in color against normal vascular age patterns and as plaque formation. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months. CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.	Control n=1587 Participants The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors
FRS, Adjusted for Baseline Values	13.33 % risk of a CVD event within 10 years Interval 13.02 to 13.64	14.13 % risk of a CVD event within 10 years Interval 13.83 to 14.44

OTHER_PRE_SPECIFIED outcome

Timeframe: Three years of follow-up, data collected during September 5 2016 - May 28 2019

SCORE: European systematic coronary risk evaluation. Risk of death (%) in myocardial infarction within 10 years expressed as statistical assessment based on smoking, systolic blood-pressure, blood cholesterol, age and sex.

SCORE is evaluated as a continuous variable with Minimum value=0%, maximum value=100%. Higher score means a worse outcome, i.e. a higher risk of cardiovascular diseases.

Outcome measures

Measure	Intervention n=1580 Participants The intervention: Giving communication about risk of cardiovascular disease in the form of written and graphical information about silent atheroscslerosis measured by carotid ultrasound examination as carotid intima-media thickness, highlighted as vascular age, and plaque formation, visualized as a traffic light (green - no plaque, red - plaque).The ultrasound results are given to the study person and his/her physician, in addition to information about conventional risk factors for cardiovascular disease Intervention: Information about carotid ultrasound results to the participant and his/her primary care physician in the form of atherosclerosis highlighted graphically in color against normal vascular age patterns and as plaque formation. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months. CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.	Control n=1587 Participants The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors
SCORE Adjusted for Baseline Levels	1.69 % risk of a CVD event within 10 years Interval 1.64 to 1.74	1.83 % risk of a CVD event within 10 years Interval 1.78 to 1.88

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 50 other events

Deaths: 5 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention n=1749 participants at risk Intervention: Pictorial information about carotid ultrasound results to the participant and his/her primary care physician. Asymptomatic atherosclerosis presented as vascular age with a gauge going from green (biological age 10 years younger than chronological age), over yellow, orange to red (10 years older). Plaque formation shown as a traffic light with a green dot (no plaque) or red dot (plaque) for each side. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months. CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.	Control n=1783 participants at risk The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.
Psychiatric disorders Anxiety	2.9% 50/1749 • Number of events 50 • 1 year	0.00% 0/1783 • 1 year

Additional Information

Dr Margareta Norberg

Umea University, Sweden

Phone: +46907865544

Email: margareta.norberg@umu.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place