NCT04656132

PAVS in Cardiology

Completed Phase 1 Results posted Last updated 7 August 2024

What this trial tests

Phase 1 trial testing Physical activity assessment, promotion and monitoring in a preventive cardiology clinic in Cardiovascular Diseases in 63 participants. Completed in 10 August 2022.

Timeline

14 July 2021

Primary endpoint
10 August 2022

10 August 2022

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	63
Start date	14 July 2021
Primary completion	10 August 2022
Estimated completion	10 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Physical activity assessment, promotion and monitoring in a preventive cardiology clinic

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

NYU Langone Health — full company profile →

Who can join

18 and older, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Step Counts Primary · Month 3

Pedometer

Group	Value	95% CI
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors	48770	± 27362

BMI Primary · Month 3

BMI will be calculated by height and weight measured at the time of the Center visit on a balance beam scale.

Group	Value	95% CI
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors	30	± 7

Waist Circumference Primary · Month 3

Waist Circumference will be measured to the nearest inch using standard technique

Group	Value	95% CI
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors	38.9	± 6

Blood Pressure Primary · Month 3

Blood pressure (BP) will be measured in right arm (unless contraindicated) after sitting for 5 minutes and repeated after a 5-minute interval. Both will be recorded and the average used in analyses.

Systolic

Group	Value	95% CI
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors	125	± 16

Diastolic

Group	Value	95% CI
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors	76	± 14

Blood Lipid Levels Primary · Month 3

Total cholesterol, HDL, and triglycerides will be measured by CLIA-waived Alere Cholestech LDX® Analyzer which is certified by the Center for Disease Control's Lipid Standardization Program and Cholesterol Reference Method Laboratory Method Network. This will be measured by a single fingerstick using standard aseptic technique.

Cholesterol

Group	Value	95% CI
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors	148	± 45

HDL

Group	Value	95% CI
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors	43	± 18

Triglycerides

Group	Value	95% CI
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors	138	± 76

Framingham Heart Study Risk Score Primary · Month 3

The Framingham Heart Study Risk Score (10-year risk) will be calculated using the appropriate risk model based on participants' age, gender, diabetes status and prior coronary heart disease. Risk is considered low if the FRS is less than 10%, moderate if it is 10% to 19%, and high if it is 20% or higher.

Group	Value	95% CI
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors	8.6	± 9.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors

Serious: 1/63 (2%)

Deaths: 0/63

Serious adverse events (1 terms)

Reaction	System	Participants With Cardiova…
Hospitalization for an Asthma Exacerbation	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Participants With Cardiova…
Hip Fracture	General disorders	—

Most-reported serious reactions: Hospitalization for an Asthma Exacerbation.

Data from ClinicalTrials.gov NCT04656132 adverse events section.

Sponsor's own description

Brief Summary This is a pilot study implemented physical activity assessment, promotion and monitoring in patients. Patients will be assessed by the physical activity vital sign (PAVS) during check-in for their appointment. During their visit with the cardiologist, a clinical decision support tool will alert the cardiologist to patients achieving low (\<50% of recommended) physical activity. The cardiologist may refer the patient to cardiac rehabilitation if appropriate and/or counsel them to increase their physical activity levels. The patients may opt to enroll in the monitoring phase of the study. They will be given a Fitbit pedometer and their Fitbit account can sync to their MyChart account. After that sync, the patients step counts will be available for their cardiologists to review as needed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Implementing a Clinical Decision Support Tool to Improve Physical Activity.
   McCarthy MM, Szerencsy A, Taza-Rocano L, Hopkins S, et al · · 2024 · PMID 38207172 · DOI 10.1097/nnr.0000000000000714