Coronary AtherosclerosisNCT02076802
Regular Physical Exercise and Salt Diet on Coronary Artery Disease in Patients With Prehypertension(RESTRAIN Pre-HT)
An observational study of Coronary Atherosclerosis and Cardiovascular Disease, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
The epidemic data shows that prehypertension is associated with cardiovascular disease, and heavy dietary salt intake could improve the developing of hypertension. We detected the risk factors of coronary atherosclerosis of prehypertensive patients with different levels of salt intake. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Coronary Atherosclerosis, Cardiovascular Disease
- What is being tested?
- physical exercises
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Sep 2014
- How long will I take part?
- 5 Years
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Coronary atherosclerosis patients with prehypertension
Who may be able to join
- aged 45-75 Admission systolic BP between 120 and 139mmHg or diastolic BP between 80 and 89mmHg coronary artery stenosis was 30%-70% -
Who cannot join
- with a history of myocardial infarction, coronary revascularization, congenital heart disease and cerebrovascular diseases
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Shenyang Militaly Region
Shenyang, Liaoning, 100016
Han Yaling
Zhao Xin
About this study
Official title: Regular Physical Exercise and Salt Diet Effect on Progression of Coronary Disease in Patients With Prehypertension
The epidemic data shows that prehypertension is associated with cardiovascular disease, and heavy dietary salt intake could improve the developing of hypertension. We detected the risk factors of coronary atherosclerosis of prehypertensive patients with different levels of salt intake.
The aim of this multicenter prospective, randomized controlled study is to evaluate regular physical exercise and salt diet effects on progression of coronary artery disease in patients with prehypertension.
- Conditions
- Coronary Atherosclerosis, Cardiovascular Disease
- Being tested
- physical exercises
- Keywords
- prehypertension, coronary atherosclerosis, cardiovascular disease
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exercisesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| lifestyle counseling | physical exercises Receives: Behavioral: physical exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatal and nonfatal myocardial infarction, or coronary revascularization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startDec 2012
- Primary completionJul 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AtherosclerosisStudies 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
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xin Zhao, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076802
- Sponsor's protocol ID
- GHSY-20130814
- Status last verified
- Feb 2014
- First submitted
- 25 Feb 2014
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular Physical Exercise and Salt Diet Effect on Progression of Coronary Disease in Patients With Prehypertension
- ClinicalTrials.gov ID
- NCT02076802
- Acronym / sponsor ID
- GHSY-20130814
- Conditions
- Coronary Atherosclerosis, Cardiovascular Disease
- Keywords
- prehypertension, coronary atherosclerosis, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 4 Mar 2014 (estimated)
- 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.
The epidemic data shows that prehypertension is associated with cardiovascular disease, and heavy dietary salt intake could improve the developing of hypertension. We detected the risk factors of coronary atherosclerosis of prehypertensive patients with different levels of salt intake.
The aim of this multicenter prospective, randomized controlled study is to evaluate regular physical exercise and salt diet effects on progression of coronary artery disease in patients with prehypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lifestyle counseling | – | Behavioral: physical exercisesphysical exercises |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Coronary atherosclerosis patients with prehypertension
Key inclusion criteria (1 listed)
- aged 45-75 Admission systolic BP between 120 and 139mmHg or diastolic BP between 80 and 89mmHg coronary artery stenosis was 30%-70% -
Key exclusion criteria (2 listed)
- with a history of myocardial infarction, coronary revascularization, congenital heart disease and cerebrovascular diseases
- -
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 exercises | Behavioural | lifestyle counseling |
Primary outcome
fatal and nonfatal myocardial infarction, or coronary revascularization
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
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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.
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 Coronary Atherosclerosis and Cardiovascular Disease, run by General Hospital of Shenyang Military Region 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 2 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 4 Mar 2014. 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 Han Yaling (+86-24-23922184, hanyal@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fatal and nonfatal myocardial infarction, or coronary revascularization (time frame: 6 months). 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 4 Mar 2014.