NCT02076802

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 4, 2014

Status Verified

February 1, 2014

Enrollment Period

1.6 years

First QC Date

February 25, 2014

Last Update Submit

February 28, 2014

Conditions

Keywords

prehypertensioncoronary atherosclerosiscardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • fatal and nonfatal myocardial infarction, or coronary revascularization

    6 months

Study Arms (1)

lifestyle counseling

physical exercises

Behavioral: physical exercises

Interventions

lifestyle counseling

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Coronary atherosclerosis patients with prehypertension

You may qualify if:

  • aged 45-75 Admission systolic BP between 120 and 139mmHg or diastolic BP between 80 and 89mmHg coronary artery stenosis was 30%-70% -

You may not qualify if:

  • with a history of myocardial infarction, coronary revascularization, congenital heart disease and cerebrovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Shenyang Militaly Region

Shenyang, Liaoning, 100016, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseCardiovascular DiseasesPrehypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 25, 2014

First Posted

March 4, 2014

Study Start

December 1, 2012

Primary Completion

July 1, 2014

Study Completion

September 1, 2014

Last Updated

March 4, 2014

Record last verified: 2014-02

Locations