Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease

Cardiovascular Primary Prevention Strategy Clinical Trial

— RESPECT  

Official title:

Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease: a Community-based, Prospective Randomised Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05431309
• Other study ID #: ZRui
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: November 30, 2028

Study information

• Verified date: July 2022
• Source: Jinling Hospital, China
• Contact: Longjiang Zhang, MD
• Phone: +8613405833176
• Email: kevinzhlj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy will be superior to traditional CHD prevention strategy, in reducing the future risk of CHD which included myocardial infarction, angina, cardiac death, and an emergency/urgent coronary revascularisation procedure, in a community population aged 40 to 69 years with cardiovascular risk factors but no history of cardiovascular disease.

Description:

Recent studies found that the incidence of CAD, screening with CCTA, in the general population is as high as 42%~49%. However, the effectiveness of CCTA screening in the primary prevention of CHD is unclear. The investigators designed a randomized controlled, open-label, pragmatic study to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy will be superior to traditional CHD prevention strategy. Community volunteers aged 40 to 69 years who provide consent, and are eligible (with cardiovascular risk factors but no history of cardiovascular disease), will be randomized 1:1 to receive individualized primary prevention programs for CHD, including statin recommendation, based on CCTA results or traditional risk assessment results using the Chinese guideline on the primary prevention of cardiovascular diseases-recommended strategy. All subjects will be followed for 5 years, but until the target primary endpoint event is met. The primary composite outcome was the first occurrence of CHD, which included myocardial infarction, angina, cardiac death, and an emergency/urgent coronary revascularisation procedure. In order to prepare the study with high quality, the investigators will performed a pilot study prior to the initiation of patient recruitment for the main study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15000
• Est. completion date: November 30, 2028
• Est. primary completion date: November 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 69 Years

Eligibility

Inclusion Criteria:

1. Resident population aged 40-69 in Nanjing, China

2. One or more of the following cardiovascular disease risk factors must be present, as

follows:

1. Current or recent (within 12 months) smoker

2. Clinical diagnosis of hypertension (>140/90mmHg)

3. Hypercholesterolaemia (LDL=4.1mmol/L or total cholesterol>6.0 mmol/L, including familial hypercholesterolaemia)

4. Diabetes mellitus

5. Rheumatoid arthritis

6. Systemic lupus erythematosus

7. Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease, males, age<55 years; females, age<60 years)

8. Chronic kidney disease stage 3 (eGFR 30~59mL/min/1.73 m2)

Exclusion Criteria:

1. Plan to leave Nanjing within 5 years or be unable to complete the follow-up work

2. Refuse to sign informed consent or inability to understand and comply with the program process

3. Known atherosclerotic cardiovascular disease (eg. angina, coronary heart disease, stroke, transient ischemic attack, peripheral vascular disease)

4. Serious chronic kidney disease (eGFR< 30 ml/min/1.73 m2)

5. Serious liver disease or dysfunction (chronic active hepatitis and cirrhosis, or aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal)

6. Prior coronary computed tomography angiography or invasive coronary angiography within the last 5 years

7. Not appropriate to be tested due to birth planning, allergies, acute thyroid storm, etc

8. Current use of statin therapy

9. Patients with diseases that seriously affect the survival period, such as malignant tumors

10. Other conditions at the discretion of the research group

Related Conditions & MeSH terms

• Cardiovascular Primary Prevention Strategy
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Coronary Computed Tomography Angiography
Intervention strategies were selected according to CCTA results

Other:
• Standard Treatment
Traditional cardiovascular disease prevention strategy based on Chinese guideline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The first occurrence of coronary heart disease	Composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure.	5 years
Secondary	Major cardiovascular adverse events (MACE)	Number of cardiac death, myocardial infarction, emergency/urgent coronary revascularisation procedure and stroke	5 years
Secondary	Death	Number of all-cause death, cardiovascular deaths, non-cardiovascular deaths and undetermined death	5 years
Secondary	Occurrence of serious adverse events related to iodinated contrast agent	Composite outcome: contrast-induced nephropathy and severe allergoid contrast agent reaction	1 year
Secondary	Coronary interventions	Number of invasive coronary angiography and coronary revascularisation procedures	5 years
Secondary	The primary end point(composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure) in different subgroups	The primary end point(composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure) will be analyzed in prespecified subgroups, including age, sex, diabetes, smoking status, hypertension, diabetes mellitus, hyperlipidemia, Chronic kidney disease stage 3	5 years
Secondary	Diet	Measured by Food Frequency Questionnaire	at 1-year follow-up and final follow-up (5 years)
Secondary	Exercise	Change in activity levels measured through International Physical Activity Questionnaire(IPAQ)	at 1-year follow-up and final follow-up (5 years)
Secondary	Smoking cessation	Proportion of patients who changed smoking habits (%)	at 1-year follow-up and final follow-up (5 years)
Secondary	Change in cardiovascular risk factors (blood pressure)	Blood pressure(mmHg)	at 1-year follow-up and final follow-up (5 years)
Secondary	Change in cardiovascular risk factors (lipids)	Lipids(mmol/L)	at 1-year follow-up and final follow-up (5 years)
Secondary	Change in cardiovascular risk factors (body weight)	Body weight(kg)	at 1-year follow-up and final follow-up (5 years)
Secondary	Change in cardiovascular risk factors(waist circumference)	Waist circumference(cm)	at 1-year follow-up and final follow-up (5 years)
Secondary	Change in depression (PHQ-9)	Change in depression measured using Patient Health Questionnaire-9 (PHQ-9) instrument	at 1-year follow-up and final follow-up (5 years)
Secondary	Change in anxiety (GAD-7)	Change in anxiety measured using Generalized Anxiety Disorder 7-item (GAD-7) instrument	at 1-year follow-up and final follow-up (5 years)
Secondary	Change in quality of sleep(PSQI)	Change in quality of sleep measured using Pittsburgh Sleep Quality Index (PSQI) instrument	at 1-year follow-up and final follow-up (5 years)
Secondary	Change in quality of life(SF-12)	Change in quality of quality of life measured using 12-item Short-Form Health Survey Questionnaire (SF-12) instrument	at 1-year follow-up and final follow-up (5 years)
Secondary	Incidental findings in Computed Tomography Angiography group	Potential benefits and harms of the findings	at 1-year follow-up and final follow-up (5 years)
Secondary	Medication adherence( anti-hypertension agent, hypoglycemic agent, antilipemic agents, anti-platelet, etc.)	Measure adherence using follow-up questionnaires (Whether participants are taking medication, why participants are not taking it or taking it, the name, frequency, dosage and side effects of the medication participants are taking)	at 1-year follow-up and final follow-up (5 years)
Secondary	Health economics	Cost-Effectiveness analysis and Cost-Utility analysis	5 years
Secondary	Disadvantages of Radiation exposure	Radiation dose (mGy-cm)	5 years