NCT05431309Not yet recruiting
Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease
Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease: a Community-based, Prospective Randomised Controlled Study
Source: ClinicalTrials.gov · Last updated 7 Jul 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 15000 (estimated)
- First submitted
- 3 Jun 2022
- Start date
- 1 Jul 2022
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Jinling Hospital, China
- Diseases
- Coronary artery disease
- NCT number
- NCT05431309
What you commit to
- Study type: Interventional
- Planned participants: 15000
- From 1 Jul 2022 to the primary completion date, 30 Nov 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior coronary computed tomography angiography or invasive coronary angiography within the last 5 years
- Current use of statin therapy
Other illness
- Known atherosclerotic cardiovascular disease (eg. angina, coronary heart disease, stroke, transient ischemic attack, peripheral vascular disease)
- Not appropriate to be tested due to birth planning, allergies, acute thyroid storm, etc
- Patients with diseases that seriously affect the survival period, such as malignant tumors
- Other conditions at the discretion of the research group
Lab values
- 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)
Other
- 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
Who the study is looking for
- Resident population aged 40-69 in Nanjing, China
- One or more of the following cardiovascular disease risk factors must be present, as follows:
- Current or recent (within 12 months) smoker
- Clinical diagnosis of hypertension (\>140/90mmHg)
- Hypercholesterolaemia (LDL≥4.1mmol/L or total cholesterol\>6.0 mmol/L, including familial hypercholesterolaemia)
- Diabetes mellitus
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease, males, age\<55 years; females, age\<60 years)
- Chronic kidney disease stage 3 (eGFR 30\~59mL/min/1.73 m2)
Age in the registry: 40 years to 69 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.