Premature Coronary Heart DiseaseNCT04578522
Correlation Between the Severity of Coronary Artery Disease and Peripheral Arterial Stiffness in Patients With Premature Coronary Heart Disease
An observational study of Premature Coronary Heart Disease, run by Chongqing Medical University at 1 site in China.
Trial summary
Premature coronary heart disease (CHD) refers to the onset of myocardial infarction in men < 55 years old, women < 65 years old. At present, researches on early-onset coronary heart disease mostly focus on its risk factors and clinical characteristics, but there is no relevant research on the relationship between… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Coronary Heart Disease
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2020to 29 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with primary coronary heart disease were male < 55 years old and female < 65 years old
Who may be able to join
- The onset of coronary heart disease (including acute coronary syndrome and stable angina pectoris) was less than 55 years old in men and 65 years in women
Who cannot join
- Non coronary heart disease leading to chest pain (myocarditis, pericarditis, pulmonary embolism, aortic dissection, unstable angina pectoris) definite infection tumor liver and kidney insufficiency autoimmune disease acromegaly hyperthyroidism and subclinical hyperthyroidism secondary hypertension, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Dongying Zhang, doctor, +8613608398395, zdy.chris@qq.com
About this study
Premature coronary heart disease (CHD) refers to the onset of myocardial infarction in men < 55 years old, women < 65 years old. At present, researches on early-onset coronary heart disease mostly focus on its risk factors and clinical characteristics, but there is no relevant research on the relationship between early-onset myocardial infarction and atherosclerosis.
Read the detailed description
Premature coronary heart disease is defined as the first onset of male < 55 years old, female < 65 years old, confirmed by clinical examination. A number of studies have found that smokers have a significantly increased risk of acute myocardial infarction, and suggest that continued smoking is still an independent predictor of mace. These findings suggest that smoking is significantly associated with early-onset coronary heart disease. A number of studies have found that smoking can increase peripheral arterial stiffness. At present, there is no study on peripheral arterial stiffness in patients with early-onset myocardial infarction, so we suspect that peripheral arterial stiffness in patients with early-onset myocardial infarction is significantly increased
- Conditions
- Premature Coronary Heart Disease
- Keywords
- Premature coronary heart disease, Degree of coronary stenosis, arterial stiffness
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
The arterial stiffness of HFpEF patients, for exampleambulatory arterial stiffness indexbrachial ankle pulse wave velocity, ardioankle vascular index and so on.
Measured: On admission
Degree of coronary stenosis
Degree of coronary stenosis indicated by coronary angiography
Measured: On admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start29 Sep 2020 (estimated)
- Primary completion29 Sep 2021 (estimated)
- Study completion29 Sep 2021 (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.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongying Zhang, Chongqing Medical University
- Investigators
- Dongying Zhang, doctor, Study director, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578522
- Sponsor's protocol ID
- 2020-09-29
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Severity of Coronary Artery Disease and Peripheral Arterial Stiffness in Patients With Premature Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT04578522
- Acronym / sponsor ID
- 2020-09-29
- Conditions
- Premature Coronary Heart Disease
- Keywords
- Premature coronary heart disease, Degree of coronary stenosis, arterial stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 29 Sep 2020 (estimated)
- Primary completion
- 29 Sep 2021 (estimated)
- Study completion
- 29 Sep 2021 (estimated)
- First posted
- 8 Oct 2020 (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.
Premature coronary heart disease (CHD) refers to the onset of myocardial infarction in men < 55 years old, women < 65 years old. At present, researches on early-onset coronary heart disease mostly focus on its risk factors and clinical characteristics, but there is no relevant research on the relationship between early-onset myocardial infarction and atherosclerosis.
Detailed description
Premature coronary heart disease is defined as the first onset of male < 55 years old, female < 65 years old, confirmed by clinical examination. A number of studies have found that smokers have a significantly increased risk of acute myocardial infarction, and suggest that continued smoking is still an independent predictor of mace. These findings suggest that smoking is significantly associated with early-onset coronary heart disease. A number of studies have found that smoking can increase peripheral arterial stiffness. At present, there is no study on peripheral arterial stiffness in patients with early-onset myocardial infarction, so we suspect that peripheral arterial stiffness in patients with early-onset myocardial infarction is significantly increased
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with primary coronary heart disease were male < 55 years old and female < 65 years old
Key inclusion criteria (1 listed)
- The onset of coronary heart disease (including acute coronary syndrome and stable angina pectoris) was less than 55 years old in men and 65 years in women
Key exclusion criteria (1 listed)
- Non coronary heart disease leading to chest pain (myocarditis, pericarditis, pulmonary embolism, aortic dissection, unstable angina pectoris) definite infection tumor liver and kidney insufficiency autoimmune disease acromegaly hyperthyroidism and subclinical hyperthyroidism secondary hypertension, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arterial stiffness
Time frame: On admission
The arterial stiffness of HFpEF patients, for exampleambulatory arterial stiffness indexbrachial ankle pulse wave velocity, ardioankle vascular index and so on.
Degree of coronary stenosis
Time frame: On admission
Degree of coronary stenosis indicated by coronary angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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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.
Dongying Zhang, doctor study director
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Coronary Heart Disease, run by Chongqing Medical University at 1 site in 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 1 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongying Zhang, doctor (+8613608398395, zdy.chris@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness (time frame: On admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2020.