Early Prediction of Major Adverse Cardiovascular Events Using Remote Monitoring

NCT03064360 | Completed DMC

• 1 other identifier: Pro00046458
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Usual care may not identify subtle clinical changes that precede a major adverse cardiovascular event (MACE). Therefore investigators will explore the effectiveness of using biomarkers, patient reported outcomes (PROs), and patient reported informatics (PRIs) as predictors to a MACE event.

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Use of biomarkers (BNP and Troponin), PROs and PRIs, to predict a MACE event

  The outcome of interest for this study is MACE, which investigators define as a composite outcome of events including: death (all cause), non-fatal MI, non-fatal stroke, or hospitalization for heart failure. Investigators will generate subject-specific monthly summary scores for the PRI and PRO metrics. Analysis of PRO's, PRIs, and biomarker surrogates will be completed using Pearson correlations. To adjust for known risk markers of MACE, investigators will run linear regressions with levels of biomarker surrogates as individual outcomes.

  18 months

Study Arms (1)

Biomarker Testing, PROs, PRIs

Biomarker testing for cardiac biomarkers, B-type natriuretic peptide (BNP) and Troponin I (Tnl), symptom and quality of life questionnaires, and patient metrics (activity, sleep, heart rate, heart rate variability).

Other: Laboratory Biomarker Analysis; Device: Patient Activity; Behavioral: Questionnaires

Interventions

Laboratory Biomarker Analysis OTHER

Blood drawn for biomarker analysis at baseline and study exit. Finger sticks at baseline, interim, and study exit.

Biomarker Testing, PROs, PRIs

Patient Activity DEVICE

Continuous monitoring of Patient Reported Informatics (PRIs) at study entry to study completion.

Biomarker Testing, PROs, PRIs

Questionnaires BEHAVIORAL

Symptom and quality of life questionnaire at baseline, and every week following to study completion

Biomarker Testing, PROs, PRIs

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with history of Ischemic Heart Disease.

You may qualify if:

• Patient age 18 years or older
• Patient with history of Ischemic Heart Disease
• Access to iOS or Android device
• Ambulatory

You may not qualify if:

• Patient with planned revascularization or valve surgery
• Patients with acute coronary syndrome
• Patients with psychiatric or substance abuse

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• University of California, Los Angeles: collaborator
• HealthLoop: collaborator
• Neoteryx: collaborator
• California Initiative to Advance Precision Medicine: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2017
• First Posted: February 27, 2017
• Study Start: February 13, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 1, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

US (1)