A Multi-center, Prospective, Observational Study to Describe the siTuation of Blood Lipid mAnagement Among the Population With hypeRtension and/or Type 2 diabeTes in Community Health Center

A Multi-center, Prospective, Observational Study to Describe the siTuation of Blood Lipid mAnagement Among the Population With hypeRtension and/or Type 2 diabeTes in Community Health Center(START-CHC)

A multi-center, prospective, observational Study to describe the siTuation of blood lipid mAnagement among the population with hypeRtension and/or type 2 diabeTes in Community Health Center

Study Overview

• Status: Not yet recruiting
• Conditions: Lipoprotein Disorder

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: yong li; Phone Number: +86 13801753494; Email: liyong606@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

5000 patients with hypeRtension and/or type 2 diabeTes inCommunity Health Center

Description

Inclusion Criteria:

1. The informed consent form (ICF) should be signed before conducting any research-related operations
2. Age ≥18 years
3. Patients with well-diagnosed hypertension (HTN) and/or type 2 diabetes (T2DM) and have been ill for ≥ 3 months
4. The patient underwent fasting lipid analysis in the past 1 month and the data was fully recorded

Exclusion Criteria:

1.Patients with well-diagnosed atherosclerotic cardiovascular disease (ASCVD) 2. Have received any form of lipid-lowering treatment within 4 weeks before the screening period 3. The patient is currently participating in any other clinical trial except this study

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients diagnosed with hypertension or diabetes; Age ≥18 years; Patients with well-diagnosed hypertension (HTN) and/or type 2 diabetes (T2DM) and have been ill for ≥ 3 months; The patient underwent fasting lipid analysis in the past 1 month and the data was fully recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary outcome	To evaluate the blood lipid levels and current status of drug treatment in patients with CHC hypertension and/or type 2 diabetes Describe the characteristics of blood lipid treatment in patients with CHC with hypertension and/or type 2 diabetes with LDL-C between 2.6 and 4.1 mmol/L	2022.12.01

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary outcome	To evaluate the ASCVD risk stratification and the level of blood lipids in patients with CHC hypertension and/or type 2 diabetes. Evaluate the blood lipid level of patients with hypertension and/or type 2 diabetes in CHC with LDL-C between 2.6 and 4.1mmol/L (LDL-C/Non-HDL) To explore the compliance of patients with CHC hypertension and/or type 2 diabetes with LDL-C between 2.6 and 4.1 mmol/L for lipid-lowering therapy.	2022.12.01

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: Pfizer

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (ACTUAL): October 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: START-CHC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No