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Cardiovascular Primary Prevention StrategyRESPECTNCT05431309

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

A study testing Coronary Computed Tomography Angiography and Standard Treatment in people with Cardiovascular Primary Prevention Strategy, run by Jinling Hospital, China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 40 to 69 years
What is being tested?
Coronary Computed Tomography Angiography and Standard Treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15,000 participants
Where
No sites listed yet
Study dates
1 Jul 2022to 30 Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Longjiang Zhang, MD contact

+8613405833176

kevinzhlj@163.com

About this study

Official title: 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.

Read the 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.

Being tested
Coronary Computed Tomography Angiography, Standard Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary Computed Tomography AngiographyDiagnostic test

    Intervention strategies were selected according to CCTA results

  • Standard TreatmentOther

    Traditional cardiovascular disease prevention strategy based on Chinese guideline

Study groups in NCT05431309
Study groupRoleWhat they receive
CCTA-based strategy groupActive comparatorPatients will be managed following the CCTA -based coronary heart disease prevention strategy for statin initiation and follow-up.
Receives: Diagnostic Test: Coronary Computed Tomography Angiography
Traditional strategy groupSham comparatorPatients will be managed following the Traditional cardiovascular disease prevention strategy based on Chinese guideline for statin initiation and follow-up.
Receives: Other: Standard Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The first occurrence of coronary heart disease

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

    Measured: 5 years

Secondary outcomes (20)

  1. Major cardiovascular adverse events (MACE)

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

    Measured: 5 years

  2. Death

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

    Measured: 5 years

  3. Occurrence of serious adverse events related to iodinated contrast agent

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

    Measured: 1 year

  4. Coronary interventions

    Number of invasive coronary angiography and coronary revascularisation procedures

    Measured: 5 years

  5. 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

    Measured: 5 years

  6. Diet

    Measured by Food Frequency Questionnaire

    Measured: at 1-year follow-up and final follow-up (5 years)

  7. Exercise

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

    Measured: at 1-year follow-up and final follow-up (5 years)

  8. Smoking cessation

    Proportion of patients who changed smoking habits (%)

    Measured: at 1-year follow-up and final follow-up (5 years)

  9. Change in cardiovascular risk factors (blood pressure)

    Blood pressure(mmHg)

    Measured: at 1-year follow-up and final follow-up (5 years)

  10. Change in cardiovascular risk factors (lipids)

    Lipids(mmol/L)

    Measured: at 1-year follow-up and final follow-up (5 years)

  11. Change in cardiovascular risk factors (body weight)

    Body weight(kg)

    Measured: at 1-year follow-up and final follow-up (5 years)

  12. Change in cardiovascular risk factors(waist circumference)

    Waist circumference(cm)

    Measured: at 1-year follow-up and final follow-up (5 years)

  13. Change in depression (PHQ-9)

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

    Measured: at 1-year follow-up and final follow-up (5 years)

  14. Change in anxiety (GAD-7)

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

    Measured: at 1-year follow-up and final follow-up (5 years)

  15. Change in quality of sleep(PSQI)

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

    Measured: at 1-year follow-up and final follow-up (5 years)

  16. 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

    Measured: at 1-year follow-up and final follow-up (5 years)

  17. Incidental findings in Computed Tomography Angiography group

    Potential benefits and harms of the findings

    Measured: at 1-year follow-up and final follow-up (5 years)

  18. 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)

    Measured: at 1-year follow-up and final follow-up (5 years)

  19. Health economics

    Cost-Effectiveness analysis and Cost-Utility analysis

    Measured: 5 years

  20. Disadvantages of Radiation exposure

    Radiation dose (mGy-cm)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study start1 Jul 2022 (estimated)
  3. Primary completion30 Nov 2028 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
15,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05431309
Sponsor's protocol ID
ZRui
Acronym
RESPECT
Status last verified
Jul 2022
First submitted
3 Jun 2022
Last updated
7 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Computed Tomography Angiography and Standard Treatment in people with Cardiovascular Primary Prevention Strategy, run by Jinling Hospital, China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Longjiang Zhang, MD (+8613405833176, kevinzhlj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The first occurrence of coronary heart disease (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05431309.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.

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