NCT05814562Completed
Cardiovascular Precision Medicine & Remote Intervention
Cardiovascular Precision Medicine & Remote Intervention - Pilot Protocol
Source: ClinicalTrials.gov · Last updated 29 Oct 2024
Brief summary (registry, in English)
This exploratory / proof of concept study aims to evaluate whether it is possible to identify at-risk patients based on EHR review of blood pressure fluctuation over time and cholesterol levels, recruit those patients, and engage them in a remote intervention protocol.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 3 Apr 2023
- Start date
- 10 Apr 2023
- Primary completion date
- 25 Oct 2024
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- High blood pressure
- NCT number
- NCT05814562
What you commit to
- Study type: Interventional
- Participants enrolled: 25
- From 10 Apr 2023 to the primary completion date, 25 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unstable blood pressure or hyperlipidemia that may require change in therapy in the 3 months after enrolment
- Recent thromboembolic events such as a myocardial infarction, stroke, acute coronary syndrome, transient ischemic attack in the 6 months prior to enrolment
- Any arrythmia requiring medical or device therapy within 6 months prior to enrolment.
- The patient is hospitalized or was hospitalized in the last 6 months prior to enrollment. Patients hospitalized after enrollment are not excluded.
- PI decision to exclude (for example - PI determines that the patient may be harmed by the study for a reason that is not covered by the exclusion criteria)
- Withdrawal Criteria
- Participants will be withdrawn from the intervention if they wish to not be called anymore. If they agree to continue to have their data collected from the medical chart, they would not be withdrawn from the study. Patients will be withdrawn from the study (their pre-withdrawal data will be used for the primary intent-to-treat analysis unless prohibited) for the following reasons:
Other illness
- The patient is suffering from a psychiatric or developmental disorder that prevents him or her from understanding the protocol or engaging in the intervention (e.g., autistic disorder, psychosis).
- The patient is suffering from a medical disorder that makes control of blood pressure especially challenging or unlikely (e.g., end stage renal disease, uncontrolled endocrine disorders)
Lab values
- Significant heart failure (NYHA \> 2) or ejection fraction \< 50%
Other
- None of the following may be present if the patient is to be eligible for enrollment in the study:
- The investigator determines that a remote intervention paradigm is not advisable because of specific patient or environmental characteristics (investigator discretion).
- The patient dies.
- The patient becomes psychotic as defined in DSM-V, or suffers from an event that makes him or her unable to participate in the intervention (e.g. loss of hearing, loss of cognitive ability).
- The patient's care is transferred to another center, and it is impossible to get the primary and secondary outcome data.
- Patient decision
- Investigator decision
- DSMC or IRB determination related to the occurrence of an adverse event, or for any other reason.
Who the study is looking for
- The patient must meet all of below criteria to be eligible for enrollment in the study:
- The patient is \> 18 years of age at enrollment.
- The patient is followed at the cardiology clinic and was diagnosed with hypertension and hypercholesterolemia more than 12 months prior to EHR screening, and has been prescribed at least one antihypertensive medication and at least one lipid-lowering agent over the 6 months prior to EHR screening
- The patient can be reached either by phone or via an internet-enabled device.
- The patient speaks English or Spanish at a level that allows them to understand the study procedures and consent to the study.
- The coefficient of Variation (CoV) of at least three systolic blood pressure measurements present in the EHR over the 12 months prior to EHR screening is \> 10%.
Criteria the registry did not label
- Participants will be screened for eligibility using the eligibility criteria delineated below. Informed Consent will be obtained for eligible candidates.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Elmhurst Hospital Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.