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

Primary Purpose

Cardiovascular Primary Prevention Strategy

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Coronary Computed Tomography Angiography

Standard Treatment

About this trial

This is an interventional prevention trial for Cardiovascular Primary Prevention Strategy

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Resident population aged 40-69 in Nanjing, China
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:

Plan to leave Nanjing within 5 years or be unable to complete the follow-up work
Refuse to sign informed consent or inability to understand and comply with the program process
Known atherosclerotic cardiovascular disease (eg. angina, coronary heart disease, stroke, transient ischemic attack, peripheral vascular disease)
Serious chronic kidney disease (eGFR< 30 ml/min/1.73 m2)
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)
Prior coronary computed tomography angiography or invasive coronary angiography within the last 5 years
Not appropriate to be tested due to birth planning, allergies, acute thyroid storm, etc
Current use of statin therapy
Patients with diseases that seriously affect the survival period, such as malignant tumors
Other conditions at the discretion of the research group

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

CCTA-based strategy group

Traditional strategy group

Arm Description

Patients will be managed following the CCTA -based coronary heart disease prevention strategy for statin initiation and follow-up.

Patients will be managed following the Traditional cardiovascular disease prevention strategy based on Chinese guideline for statin initiation and follow-up.

Outcomes

Primary Outcome Measures

The first occurrence of coronary heart disease

Composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure.

Secondary Outcome Measures

Major cardiovascular adverse events (MACE)

Number of cardiac death, myocardial infarction, emergency/urgent coronary revascularisation procedure and stroke

Death

Number of all-cause death, cardiovascular deaths, non-cardiovascular deaths and undetermined death

Occurrence of serious adverse events related to iodinated contrast agent

Composite outcome: contrast-induced nephropathy and severe allergoid contrast agent reaction

Coronary interventions

Number of invasive coronary angiography and coronary revascularisation procedures

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

Diet

Measured by Food Frequency Questionnaire

Exercise

Change in activity levels measured through International Physical Activity Questionnaire(IPAQ)

Smoking cessation

Proportion of patients who changed smoking habits (%)

Change in cardiovascular risk factors (blood pressure)

Blood pressure(mmHg)

Change in cardiovascular risk factors (lipids)

Lipids(mmol/L)

Change in cardiovascular risk factors (body weight)

Body weight(kg)

Change in cardiovascular risk factors(waist circumference)

Waist circumference(cm)

Change in depression (PHQ-9)

Change in depression measured using Patient Health Questionnaire-9 (PHQ-9) instrument

Change in anxiety (GAD-7)

Change in anxiety measured using Generalized Anxiety Disorder 7-item (GAD-7) instrument

Change in quality of sleep(PSQI)

Change in quality of sleep measured using Pittsburgh Sleep Quality Index (PSQI) instrument

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

Incidental findings in Computed Tomography Angiography group

Potential benefits and harms of the findings

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)

Health economics

Cost-Effectiveness analysis and Cost-Utility analysis

Disadvantages of Radiation exposure

Radiation dose (mGy-cm)

Full Information

NCT ID

NCT05431309

First Posted

June 3, 2022

Last Updated

July 3, 2022

Sponsor

Jinling Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT05431309

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2022 (Anticipated)

Primary Completion Date

November 30, 2028 (Anticipated)

Study Completion Date

November 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jinling Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Primary Prevention Strategy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

15000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CCTA-based strategy group

Arm Type

Active Comparator

Arm Description

Patients will be managed following the CCTA -based coronary heart disease prevention strategy for statin initiation and follow-up.

Arm Title

Traditional strategy group

Arm Type

Sham Comparator

Arm Description

Patients will be managed following the Traditional cardiovascular disease prevention strategy based on Chinese guideline for statin initiation and follow-up.

Intervention Type

Diagnostic Test

Intervention Name(s)

Coronary Computed Tomography Angiography

Intervention Description

Intervention strategies were selected according to CCTA results

Intervention Type

Other

Intervention Name(s)

Standard Treatment

Intervention Description

Traditional cardiovascular disease prevention strategy based on Chinese guideline

Primary Outcome Measure Information:

Title

The first occurrence of coronary heart disease

Description

Composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Major cardiovascular adverse events (MACE)

Description

Number of cardiac death, myocardial infarction, emergency/urgent coronary revascularisation procedure and stroke

Time Frame

5 years

Title

Death

Description

Number of all-cause death, cardiovascular deaths, non-cardiovascular deaths and undetermined death

Time Frame

5 years

Title

Occurrence of serious adverse events related to iodinated contrast agent

Description

Composite outcome: contrast-induced nephropathy and severe allergoid contrast agent reaction

Time Frame

1 year

Title

Coronary interventions

Description

Number of invasive coronary angiography and coronary revascularisation procedures

Time Frame

5 years

Title

The primary end point(composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure) in different subgroups

Description

Time Frame

5 years

Title

Diet

Description

Measured by Food Frequency Questionnaire

Time Frame