Ambulatory Blood Pressure Monitoring in Patients With Coronary Artery Disease

NCT04649463 | Completed

• 1 other identifier: 2011-38425
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Office blood pressure (OBP) is used for diagnosing and treating hypertension but ambulatory blood pressure measurement (ABPM) associates more accurately with patient outcome. The optimal blood pressure in patients with coronary artery disease (CAD) is still unknown. Our objective was to investigate whether physician awareness of ABP after percutaneous coronary intervention (PCI) improved BP-control. Methods: A total of 201 patients performed ABPM before and after their PCI follow-up visit. Patients were randomized to open (O) or concealed (C) ABPM results for the physician at the follow-up visit. The change in ABP and antihypertensive medication in relation to baseline ABP was compared between the two groups.

Conditions

Blood Pressure; Coronary Artery Disease; Hypertension

Outcome Measures

Primary Outcomes (1)

• The primary efficacy variable was the difference between groups in change of mean night time blood pressure between the first and second ABPM.

  Change in mean systolic blood pressure as assessed by ABPM between 24.00 to 6.00 between groups (open or concealed 24-hour ABPM).

  Change in mean nighttime ABPM between first to second ABPM ( First 3-6 weeks after PCI and second 11-18 weeks after PCI)

Secondary Outcomes (1)

• Frequency of patients with 24-hour hypertensionl at 11-18 weeks after PCI

  11-18 weeks after PCI

Study Arms (2)

Open ABPM results

ACTIVE COMPARATOR

ABPM results were used in the decision making for adjustments in antihypertensive medication at follow up visit.

Diagnostic Test: Open ABPM results

Concealed ABPM results

SHAM COMPARATOR

ABPM results were not used in the decision making for adjustments in antihypertensive medication at follow up visit.

Diagnostic Test: Open ABPM results

Interventions

Open ABPM results DIAGNOSTIC_TEST

ABPM results were used in the decision making for adjustments in antihypertensive medication at follow up visit.

Concealed ABPM results; Open ABPM results

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* Patient scheduled for follow up after an acute or elective percutaneous coronary intervention (PCI) for coronary atherosclerosis at the Department of Cardiology at the Karolinska University Hospital

You may not qualify if:

• Age below 18 years
• Age above 90 years
• Severe cognitive dysfunction
• Severe somatic disease constituting an obstacle for completing follow up
• Current atrial fibrillation

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Hypertension

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jan B Östergren, MD. PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized parallell groups open

Study Record Dates

• First Submitted: November 21, 2020
• First Posted: December 2, 2020
• Study Start: April 6, 2009
• Primary Completion: May 20, 2015
• Study Completion: November 15, 2016
• Last Updated: December 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: In 2021 until 2025
• Access Criteria: Researcher with an academic affiliation