Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06471036

Test 2 Treat: A Randomized Trial to Improve LDL-C Management After Hospitalization for Atherosclerotic Cardiovascular Disease

Led by Duke University · Updated on 2025-07-25

400

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

A

Amgen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether educating doctors and providing extra support to patients who have experienced a heart event can help prevent future heart problems. This study focuses on patients hospitalized for heart events such as heart attacks and aims to see if educating doctors and using a "care champion" can improve cholesterol management. The trial is designed as an interventional study comparing usual care with added support from a care champion to see if this approach helps patients better meet their cholesterol goals. Participants are divided into two groups: one receives usual care, and the other is assigned a care champion who assists with the transition from hospital to outpatient care. Before discharge, patients in the intervention group meet the care champion virtually, receive education on their cholesterol goals, and get information about follow-up testing and appointments. The care champion communicates with patients over several months to encourage cholesterol testing and medication adherence, but does not manage prescriptions. Data will be collected from electronic health records and patient surveys over an 8-month period. Participants will complete two 15-minute phone surveys: one at enrollment and another six months later. Clinical data, including cholesterol levels, will be gathered at baseline, 6 months, and 8 months post-discharge. Researchers will monitor cholesterol changes, medication adjustments, and follow-up testing to evaluate the impact of the care champion. The study uses randomization at the site level and includes safety monitoring through patient records and discussions. Total participation lasts about 8 months after hospital discharge, with close follow-up to track outcomes.

CONDITIONS

Brief Title

Test 2 Treat: Can we Improve the Testing and Treatment of High Cholesterol in Patients Who Have Been Hospitalized for a Cardiac Event by Providing Education to Doctors and Patients?

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Hospitalized with Type 1 NSTEMI or STEMI, or underwent percutaneous coronary revascularization
  • LDL cholesterol level of 70 mg/dL or higher during hospital admission
  • Has a primary care clinician and/or cardiologist within the same health system managing outpatient care
Not Eligible

You will not qualify if you...

  • Unlikely to survive or continue follow-up in the health system for at least 6 months, including those on hospice or with significant dementia
  • Underwent coronary artery bypass graft surgery (CABG) and discharged from surgical service

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Intervention

Duration - 6 months post-discharge

Participants randomized to the intervention arm will receive support from a care champion who helps manage lipid lowering therapy adherence, LDL-C retesting, and outpatient follow-up after hospital discharge.

Ongoing communication with care champion during 6 months

Standard of Care

Duration - 6 months post-discharge

Participants randomized to standard care will receive usual follow-up without additional support from a care champion.

No additional visits beyond routine care

Follow-up and Monitoring

Duration - 2 months post-intervention (6 to 8 months post-discharge)

Participants are monitored for LDL-C levels and lipid-lowering therapy changes. Clinical Research Coordinators will prompt LDL-C testing at 6 months if not already done and review electronic health records at 8 months post-discharge to collect final LDL-C values.

1 to 2 contacts for LDL-C testing encouragement and EHR review

Trial Site Locations

Total: 1 location

1

Allina Health

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

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Research Team

N

Neha Pagidipati, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

Scott M Grundy, Neil J Stone, Alison L Bailey...

https://pubmed.ncbi.nlm.nih.gov/30423391

2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines.

Salim S Virani, L Kristin Newby, Suzanne V Arnold...

https://pubmed.ncbi.nlm.nih.gov/37471501

Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial.

G G Schwartz, A G Olsson, M D Ezekowitz...

https://pubmed.ncbi.nlm.nih.gov/11277825

Long-term benefit of statin therapy initiated during hospitalization for an acute coronary syndrome: a systematic review of randomized trials.

Anthony A Bavry, Girish R Mood, Dharam J Kumbhani...

https://pubmed.ncbi.nlm.nih.gov/17503884

Early statin treatment following acute myocardial infarction and 1-year survival.

U Stenestrand, L Wallentin, Swedish Register of Cardiac Intensive Care (RIKS-HIA)

https://pubmed.ncbi.nlm.nih.gov/11242427

Effect of a Hospital and Postdischarge Quality Improvement Intervention on Clinical Outcomes and Quality of Care for Patients With Heart Failure With Reduced Ejection Fraction: The CONNECT-HF Randomized Clinical Trial.

Adam D DeVore, Bradi B Granger, Gregg C Fonarow...

https://pubmed.ncbi.nlm.nih.gov/34313687