Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColorado Prevention Center

About this trial

This is a randomized, controlled, collaborative, multicenter, pilot implementation science study evaluating the hypothesis that algorithm- and multi-professional team-supported lipid management reduces low density lipoprotein-cholesterol (LDL-C) compared with usual care in patients with atherosclerotic cardiovascular disease (ASCVD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provided informed consent

Age >18 years inclusive at screening

Coronary artery disease (prior revascularization, myocardial infarction, imaging evidence of coronary atherosclerosis)

Peripheral artery disease (prior revascularization, amputation, ankle: brachial index (ABI) ≤ 0.90, imaging evidence of extra-coronary atherosclerosis)

Disqualifiers

Any reason that, in the opinion of the investigator, the patient would be unable to adhere to the protocol for the duration of the study (e.g. terminal diagnosis, metastatic cancer) or in whom participation might result in harm.

Planned active titration of current lipid-lowering therapy

Myocardial infarction or arterial revascularization within prior 30 days

Trial design

Design model

Parallel

Treatments tested in this trial

  • Algorithm- and multi-professional team-supported lipid management

    Other intervention

    Algorithm- and multi-professional team-supported lipid management

  • Guideline-directed lipid management by usual care provider

    Other intervention

    Guideline-directed lipid management by usual care provider

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Control: Guideline-directed lipid management by usual care providerOther 1 intervention
Group B: Algorithm- and multi-professional team-supported lipid managementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The between group difference in LDL-C percent change

Time frame
Baseline to 3 months

Secondary outcomes

1

Between group difference

LDL-C percent change

Time frame
Baseline to 1 and 6 months
2

Between group difference

The proportion achieving LDL-C \<55 mg/dL

Time frame
1, 3 and 6 months
3

Between group difference

Proportion receiving combination lipid lowering Therapy

Time frame
1, 3 and 6 months

Other outcomes

Sponsors and contacts

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