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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Primary Prevention Strategy
• Intervention / Treatment: Diagnostic test: Coronary Computed Tomography Angiography; Other: Standard Treatment

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 15000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Longjiang Zhang, MD; Phone Number: +8613405833176; Email: kevinzhlj@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CCTA-based strategy group; Patients will be managed following the CCTA -based coronary heart disease prevention strategy for statin initiation and follow-up.	Diagnostic test: Coronary Computed Tomography Angiography; Intervention strategies were selected according to CCTA results
Sham Comparator: Traditional strategy group; Patients will be managed following the Traditional cardiovascular disease prevention strategy based on Chinese guideline for statin initiation and follow-up.	Other: Standard Treatment; Traditional cardiovascular disease prevention strategy based on Chinese guideline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The first occurrence of coronary heart disease	Composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major cardiovascular adverse events (MACE)	Number of cardiac death, myocardial infarction, emergency/urgent coronary revascularisation procedure and stroke	5 years
Death	Number of all-cause death, cardiovascular deaths, non-cardiovascular deaths and undetermined death	5 years
Occurrence of serious adverse events related to iodinated contrast agent	Composite outcome: contrast-induced nephropathy and severe allergoid contrast agent reaction	1 year
Coronary interventions	Number of invasive coronary angiography and coronary revascularisation procedures	5 years
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
Diet	Measured by Food Frequency Questionnaire	at 1-year follow-up and final follow-up (5 years)
Exercise	Change in activity levels measured through International Physical Activity Questionnaire(IPAQ)	at 1-year follow-up and final follow-up (5 years)
Smoking cessation	Proportion of patients who changed smoking habits (%)	at 1-year follow-up and final follow-up (5 years)
Change in cardiovascular risk factors (blood pressure)	Blood pressure(mmHg)	at 1-year follow-up and final follow-up (5 years)
Change in cardiovascular risk factors (lipids)	Lipids(mmol/L)	at 1-year follow-up and final follow-up (5 years)
Change in cardiovascular risk factors (body weight)	Body weight(kg)	at 1-year follow-up and final follow-up (5 years)
Change in cardiovascular risk factors(waist circumference)	Waist circumference(cm)	at 1-year follow-up and final follow-up (5 years)
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)
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)
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)
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)
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)
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)
Health economics	Cost-Effectiveness analysis and Cost-Utility analysis	5 years
Disadvantages of Radiation exposure	Radiation dose (mGy-cm)	5 years

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Investigators: Study Chair: Trial Manager, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): November 30, 2028
• Study Completion (Anticipated): November 30, 2028

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 3, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: ZRui

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No