Premature Coronary Heart DiseasePRE-CARDIANCT06695182

the Real-world Data of Risk Factor and Its Prognosis in PREmature Coronary ARtery DIseAse Study

An observational study of Premature Coronary Heart Disease, run by Sun Yat-sen University.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

The goal of this observational study is to explore the relationship between biological aging and long-term prognosis of patients with metabolic cardiovascular disease in premature coronary artery disease. The main question[s] it aims to answer [is/are]: 1. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Premature Coronary Heart Disease
What is being tested?: physical activity
Type of treatment: Lifestyle or therapy programme
How many people: 3,000 participants
Where: No sites listed yet
Study dates: Oct 2013to Mar 2027
How long will I take part?: 10 Years
Phase: Observational
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: This study adopts a single-center, one-arm and historical prospective cohort design, and plans to retrospectively collect the data of patients with metabolic cardiovascular diseases hospitalized in the Department of Cardiovascular Medicine of the First Affiliated Hospital of Sun Yat-sen University from January 2013 to now through the electronic medical record system.

Who may be able to join

Male or female inpatients over 18 years old in the Department of Cardiovascular Medicine;
Patients with one of the following metabolic cardiovascular diseases [17]: including diabetes, hypertension, coronary heart disease, heart failure, cerebral infarction, dyslipidemia, obesity and hyperuricemia;
Those who have corresponding inspection data so as to be able to calculate the biological age;
Obtaining oral informed consent or signing an informed consent form;

Who cannot join

·NA

About this study

Official title: the Real-world Data of Risk Factor and Its Prognosis in PREmature Coronary ARtery DIseAse Study (PRE-CARDIA)

Do patients with premature coronary heart disease have accelerated biological aging?
What is the prognosis of accelerated biological aging in patients with premature coronary heart disease?

Conditions: Premature Coronary Heart Disease
Being tested: physical activity
Keywords: Premature coronary heart disease, Risk factor, aging

What participants receive

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

physical activityBehavioural

Study groups in NCT06695182
Study group	Role	What they receive
premature coronary artery disease		Not described Receives: Behavioral: physical activity

What is being measured

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

International physical activity questionnaire
The duration and form of exercise (low, moderate and high intensity) was reported in the form of recall, with higher scores representing more exercise.
Measured: Baseline.
Accelerometer
Record participants' daily exercise, more objective than questionnaires.
Measured: Up to 8 weeks.
Cardiopulmonary test
Representation of extreme and sub-extreme motion.
Measured: Up to 8 weeks.
Glucose
Measurement of fasting blood glucose levels to evaluate changes in glucose metabolism and glycemic control. Fasting blood samples are collected in the morning following an 8- to 12-hour fast. Blood glucose concentration is measured in milligrams per deciliter (mg/dL) using a standardized laboratory analyzer to ensure accuracy and consistency.
Measured: Up to 8 weeks.
Hemoglobin A1c (HbA1c)
Measurement of Hemoglobin A1c (HbA1c) levels to evaluate long-term glycemic control over the past 2-3 months. HbA1c is measured as a percentage using a high-performance liquid chromatography (HPLC) method, providing an indication of average blood glucose levels.
Measured: Up to 8 weeks.
Serum creatinine
Measurement of serum creatinine levels to assess renal function and monitor potential changes over time. Serum creatinine is measured in milligrams per deciliter (mg/dL) using an enzymatic assay in a certified laboratory. This measurement serves as a key indicator of kidney function and is used to calculate the estimated glomerular filtration rate (eGFR) as an additional marker of renal health.
Measured: Up to 8 weeks.
Lipid
Measurement of lipid profile, including total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides, to evaluate cardiovascular risk and lipid metabolism. Fasting blood samples are collected after an 8- to 12-hour fast and analyzed in a certified laboratory using enzymatic colorimetric assays. Results are expressed in milligrams per deciliter (mg/dL).
Measured: Up to 8 weeks.
Serum uric acid
Measurement of serum uric acid levels to assess purine metabolism and monitor for potential hyperuricemia. Serum uric acid is measured in milligrams per deciliter (mg/dL) using an enzymatic colorimetric method in a certified laboratory. This measure provides insight into kidney function and potential risk of gout.
Measured: Up to 8 weeks.
Blood urea nitrogen
Measurement of blood urea nitrogen (BUN) levels to evaluate kidney function and protein metabolism. BUN is measured in milligrams per deciliter (mg/dL) using an enzymatic assay in a certified laboratory, offering an indicator of renal health and nitrogen balance.
Measured: Up to 8 weeks.

Secondary outcomes (4)

Center for Epidemiologic Studies Depression Scale (CES-D)
Assessment of depressive symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D), a validated 20-item self-report questionnaire that measures the frequency of depressive symptoms experienced in the past week. Each item is scored on a 4-point Likert scale, ranging from 0 (rarely or none of the time) to 3 (most or all of the time), with a total score range of 0-60. Higher scores indicate more severe depressive symptoms.
Measured: Up to 8 weeks.
uroQol 5-Dimension 5-Level (EQ-5D-5L)
Assessment of health-related quality of life using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. This tool measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, ranging from no problems to extreme problems, resulting in a single health state index score. Additionally, participants provide a self-rated health score on a visual analog scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate better health-related quality of life.
Measured: Up to 8 weeks.
Multidimensional Sports Self-efficacy Scale (MSES)
Assessment of sports-related self-efficacy using the Multidimensional Sports Self-efficacy Scale (MSES), a validated questionnaire measuring an individual's confidence in performing various aspects of sports performance. The MSES includes subscales for different dimensions, such as physical skill, self-regulation, and coping with pressure. Each item is rated on a Likert scale from 1 (not at all confident) to 7 (extremely confident), with higher scores indicating greater self-efficacy in sports-related skills and resilience.
Measured: Up to 8 weeks.
Chinese self-efficacy for exercise scale (SEE-C)
Assessment of self-efficacy for exercise using the Chinese Self-Efficacy for Exercise Scale (SEE-C), a validated questionnaire designed to measure an individual's confidence in their ability to engage in and sustain exercise. The SEE-C consists of several items that assess self-efficacy across various domains such as initiation, maintenance, and overcoming barriers to exercise. Each item is rated on a Likert scale from 1 (not at all confident) to 5 (extremely confident), with higher scores reflecting greater confidence in one's ability to engage in regular physical activity.
Measured: Up to 8 weeks.

Timeline

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

Oct 2013Mar 2027

First posted19 Nov 2024
Study startOct 2013
Primary completionNov 2024 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Premature Coronary Heart DiseaseStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 3,000 participants (actual)
Target duration: 10 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT06695182
Sponsor's protocol ID: PRE-CARDIA study
Acronym: PRE-CARDIA
Status last verified: Nov 2024
First submitted: 5 Nov 2024
Last updated: 19 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
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Physical Impairments in Premature Ventricular Complex
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All Premature Coronary Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: the Real-world Data of Risk Factor and Its Prognosis in PREmature Coronary ARtery DIseAse Study (PRE-CARDIA)
ClinicalTrials.gov ID: NCT06695182
Acronym / sponsor ID: PRE-CARDIA / PRE-CARDIA study
Conditions: Premature Coronary Heart Disease
Keywords: Premature coronary heart disease, Risk factor, aging
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 3,000 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Collaborators: First Affiliated Hospital, Sun Yat-Sen University
Study start: Oct 2013 (actual)
Primary completion: Nov 2024 (estimated)
Study completion: Mar 2027 (estimated)
First posted: 19 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Do patients with premature coronary heart disease have accelerated biological aging?
What is the prognosis of accelerated biological aging in patients with premature coronary heart disease?

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Target follow-up: 10 Years
Number of arms: 1

Arm	Type	Receives
premature coronary artery disease	–	Behavioral: physical activity

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This study adopts a single-center, one-arm and historical prospective cohort design, and plans to retrospectively collect the data of patients with metabolic cardiovascular diseases hospitalized in the Department of Cardiovascular Medicine of the First Affiliated Hospital of Sun Yat-sen University from January 2013 to now through the electronic medical record system.

Key inclusion criteria (4 listed)

Male or female inpatients over 18 years old in the Department of Cardiovascular Medicine;
Patients with one of the following metabolic cardiovascular diseases [17]: including diabetes, hypertension, coronary heart disease, heart failure, cerebral infarction, dyslipidemia, obesity and hyperuricemia;
Those who have corresponding inspection data so as to be able to calculate the biological age;
Obtaining oral informed consent or signing an informed consent form;

Key exclusion criteria (1 listed)

·NA

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
physical activity	Behavioural	premature coronary artery disease

Primary outcome

International physical activity questionnaire
Time frame: Baseline.
The duration and form of exercise (low, moderate and high intensity) was reported in the form of recall, with higher scores representing more exercise.
Accelerometer
Time frame: Up to 8 weeks.
Record participants' daily exercise, more objective than questionnaires.
Cardiopulmonary test
Time frame: Up to 8 weeks.
Representation of extreme and sub-extreme motion.
Glucose
Time frame: Up to 8 weeks.
Measurement of fasting blood glucose levels to evaluate changes in glucose metabolism and glycemic control. Fasting blood samples are collected in the morning following an 8- to 12-hour fast. Blood glucose concentration is measured in milligrams per deciliter (mg/dL) using a standardized laboratory analyzer to ensure accuracy and consistency.
Hemoglobin A1c (HbA1c)
Time frame: Up to 8 weeks.
Measurement of Hemoglobin A1c (HbA1c) levels to evaluate long-term glycemic control over the past 2-3 months. HbA1c is measured as a percentage using a high-performance liquid chromatography (HPLC) method, providing an indication of average blood glucose levels.
Serum creatinine
Time frame: Up to 8 weeks.
Measurement of serum creatinine levels to assess renal function and monitor potential changes over time. Serum creatinine is measured in milligrams per deciliter (mg/dL) using an enzymatic assay in a certified laboratory. This measurement serves as a key indicator of kidney function and is used to calculate the estimated glomerular filtration rate (eGFR) as an additional marker of renal health.
Lipid
Time frame: Up to 8 weeks.
Measurement of lipid profile, including total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides, to evaluate cardiovascular risk and lipid metabolism. Fasting blood samples are collected after an 8- to 12-hour fast and analyzed in a certified laboratory using enzymatic colorimetric assays. Results are expressed in milligrams per deciliter (mg/dL).
Serum uric acid
Time frame: Up to 8 weeks.
Measurement of serum uric acid levels to assess purine metabolism and monitor for potential hyperuricemia. Serum uric acid is measured in milligrams per deciliter (mg/dL) using an enzymatic colorimetric method in a certified laboratory. This measure provides insight into kidney function and potential risk of gout.
Blood urea nitrogen
Time frame: Up to 8 weeks.
Measurement of blood urea nitrogen (BUN) levels to evaluate kidney function and protein metabolism. BUN is measured in milligrams per deciliter (mg/dL) using an enzymatic assay in a certified laboratory, offering an indicator of renal health and nitrogen balance.

4 secondary outcomes

Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Up to 8 weeks.
uroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Up to 8 weeks.
Multidimensional Sports Self-efficacy Scale (MSES)
Time frame: Up to 8 weeks.
Chinese self-efficacy for exercise scale (SEE-C)
Time frame: Up to 8 weeks.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.

Related trials for Premature Coronary Heart Disease

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Not yet recruitingObservational study
Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life
Cardiac Abnormalities, Nutrient Intake
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Premature Coronary Heart Disease, run by Sun Yat-sen University.

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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2024. 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International physical activity questionnaire (time frame: Baseline.). The study lists 9 primary outcomes in all. 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 NCT06695182.

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 19 Nov 2024.