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NCT Number: NCT06640400

Cardiovascular Ultrasound for the Rehabilitation of Patients With Coronary Heart Disease After PCI

The goal of this clinical trial is to learn the efficacy of cardiovascular ultrasound therapy on the rehabilitation of patients with coronary heart disease after PCI. It will also learn about the safety of cardiovascular ultrasound. The main questions it aims to answer are:

Whether cardiovascular ultrasound improves cardiac function and prognosis in patients with coronary artery disease after PCI? What medical problems will participants experience after using cardiovascular ultrasound therapy? Researchers will compare cardiovascular ultrasound to a placebo (sham stimulation) to see if cardiovascular ultrasound works to treat coronary artery disease after PCI.

Participants will:

Patients were treated with cardiovascular ultrasound or placebo from the 24th hour after PCI for 20 minutes twice a day for 10 days.

Examination and detection of serum inflammatory markers, endothelial function indicators, cardiac function, and heart rate variability at multiple time points (baseline (24 hours post-PCI), days 5 and 10 post-intervention, and months 1 and 3.

Their symptoms were recorded, and depression and anxiety were scored.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Background Coronary heart disease (CHD) is one of the leading causes of mortality and disability and places a financial burden on the healthcare system. Although cardiovascular ultrasound has shown its effectiveness and safety in improving refractory angina, relevant clinical studies are rare, and clinical evidence is severely lacking.

Methods and design This is a prospective, parallel-group, randomized control trial. We will enroll 200 patients with coronary artery disease after PCI and randomize them into 2 groups. The intervention group was given usual practice combined with cardiovascular ultrasound intervention and the control group was given usual practice combined with empty stimulation intervention. We used hs-CRP and IL-6 levels in serum after 20 times treatments with LIPUS as the primary outcome measures. Serum myocardial injury indicators levels and blood lipids indicators levels, markers of endothelial function levels, inflammatory factor levels, hemodynamic Indicators, Echocardiogram, 6-minute walk test, Short-term Heart rate variability, and mental health assessment were secondary outcomes. The researchers tested the outcome indicators at baseline (24th hours after PCI), 5th and 10th days, and 1st and 3rd months after the intervention. Statistical analyses were performed using SPSS 26.0 statistical software.

Discussion This study is the first clinical study of the rehabilitation efficacy of cardiovascular ultrasound in the treatment of coronary heart disease after PCI. Given that the current clinical recovery mainly depends on the body's self-limiting and conventional symptomatic treatment, Cardiovascular ultrasound, as a new therapy method, might be a major advance in the treatment of coronary heart disease after PCI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of enrollment at least 18 years 2. Patients with confirmed coronary artery disease requiring elective PCI 3. TIMI flow grade 2 or above after PCI 4. No intraoperative complications of PCI such as entrapment, reflux, or perforation of coronary artery.
  • The skin in the anterior chest area is intact and not broken. 6. Cardiac enzymes and troponin I are within normal range before enrollment. Exclusion Criteria
  • Patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction.
  • Occlusion of branch vessels during PCI.
  • Patients with perioperative use of hormones or immunosuppressants
  • Combined infection or other inflammatory diseases
  • Postoperative fever
  • Patients are allergic to contrast media or cardiovascular ultrasound acoustic head-related materials.
  • Changes in lipid-lowering, antiplatelet, and antihypertensive drug regimens during treatment.
  • Patients with a clear diagnosis of autoimmune disease
  • Patients who have undergone other surgeries in the past 7 days or have a history of trauma.
  • Patients infected with novel coronavirus in the past month.
  • Previous PCI treatment
  • Previous cardiovascular ultrasound treatment
  • Diabetic patients

Treatment and study plan

Cardiovascular ultrasound

Device

Participants in the intervention group will be treated with a medical LIPUS device (838C-M-L-I/II, Shenzhen, China) for 10 days in addition to conventional medical treatment. The ultrasound therapy instrument is equipped with a sound head comprising 5 transducer units, operating at an ultrasonic frequency of 0.84MHz with a sound intensity range of 1 W/cm2 -1.25 W/cm2. The therapeutic ultrasound sessions necessitate a controlled environmental temperature. Patients will assume the supine position, exposing the precordial region, with the five-pronged head positioned parallel to the heart's long axis, covering the entire precordial region including the right and left coronary arterial trunks and the aortic root. The ultrasound therapy device operates in a pulsed mode, with each treatment session lasting 20 minutes, comprising 2 daily sessions for a total of 20 treatments.

Primary outcomes

  1. high-sensitivity C-reactive protein (hs-CRP) in serum

    Time frame: Day 11 after PCI

    High-sensitivity C-reactive protein (hs-CRP) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions.

  2. Interleukin-6 (IL-6) levels

    Time frame: Day 11 after PCI

    high-sensitivity C-reactive protein (hs-CRP) and Interleukin-6 (IL-6) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions

Secondary outcomes

  1. creatine kinase isoenzymes

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum creatine kinase isoenzyme levels in fasting were collected and measured

  2. cardiac troponin I

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum cardiac troponin I levels in fasting were collected and measured

  3. myeloperoxidase

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum myeloperoxidase levels in fasting were collected and measured.

  4. total cholesterol

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum total cholesterol levels in fasting were collected and measured

  5. triglyceride

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum triglyceride levels in fasting were collected and measured.

  6. low-density lipoprotein cholesterol

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum low-density lipoprotein cholesterol levels in fasting were collected and measured.

  7. high-density lipoprotein cholesterol

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum high-density lipoprotein cholesterol levels in fasting were collected and measured.

  8. apolipoprotein A

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum apolipoprotein A levels in fasting were collected and measured.

  9. apolipoprotein B

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum apolipoprotein B levels in fasting were collected and measured.

  10. lipoprotein (a)

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum lipoprotein (a) levels in fasting were collected and measured.

  11. oxidized low-density lipoprotein

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum-oxidized low-density lipoprotein levels in fasting were collected and measured.

  12. endothelial nitric oxide synthase

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum endothelial nitric oxide synthase levels in fasting were collected and measured.

  13. endothelin-1

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum endothelin-1 levels in fasting were collected and measured.

  14. vascular endothelial growth factor

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum vascular endothelial growth factor levels in fasting were collected and measured.

  15. procalcitonin

    Time frame: From enrollment to the end of treatment at 3rd month

    Serum procalcitonin levels in fasting were collected and measured.

  16. Systemic Vascular Resistance

    Time frame: From enrollment to the end of treatment at 3rd month

    Stroke Systemic Vascular Resistance Index was collected and measured.

  17. Mean Arterial Pressure

    Time frame: From enrollment to the end of treatment at 3rd month

    Mean Arterial Pressure was collected and measured.

  18. Stroke Volume Index

    Time frame: From enrollment to the end of treatment at 3rd month

    Stroke Volume Index was collected and measured.

  19. Stroke Volume

    Time frame: From enrollment to the end of treatment at 3rd month

    Stroke Volume levels was collected and measured.

  20. Cardiac Output

    Time frame: From enrollment to the end of treatment at 3rd month

    Cardiac Output was collected and measured.

  21. Cardiac Index

    Time frame: From enrollment to the end of treatment at 3rd month

    The Cardiac Index was collected and measured.

  22. Left Ventricular Stroke Work Index

    Time frame: From enrollment to the end of treatment at 3rd month

    The left Ventricular Stroke Work Index was collected and measured.

  23. Systemic Vascular Resistance Index

    Time frame: From enrollment to the end of treatment at 3rd month

    The systemic Vascular Resistance Index was collected and measured.

  24. Ejection Phase Contraction Index

    Time frame: From enrollment to the end of treatment at 3rd month

    Ejection Phase Contraction Index was collected and measured.

  25. Inotropic State Index

    Time frame: From enrollment to the end of treatment at 3rd month

    Inotropic State Index was collected and measured.

  26. Systemic Vascular Resistance

    Time frame: From enrollment to the end of treatment at 3rd month

    Systemic Vascular Resistance was collected and measured.

  27. Vascular Resistance

    Time frame: From enrollment to the end of treatment at 3rd month

    Vascular Resistance was collected and measured.

  28. Mean Heart Rate

    Time frame: From enrollment to the end of treatment at 3rd month

    Mean Heart Rate was collected and measured.

  29. left ventricular ejection fraction

    Time frame: From enrollment to the end of treatment at 3rd month

    left ventricular ejection fraction was collected and measured

  30. Wall thickening fraction

    Time frame: From enrollment to the end of treatment at 3rd month

    Wall thickening fraction was collected and measured.

  31. E/E'

    Time frame: From enrollment to the end of treatment at 3rd month

    E/E' was collected and measured.

  32. 6-minute walk test

    Time frame: From enrollment to the end of treatment at 3rd month

    A 6-minute walk test was collected and measured.

  33. Patient Health Questionnaire-9

    Time frame: From enrollment to the end of treatment at 3rd month

    Patient Health Questionnaire-9 was scored and collected. The Patient Health Questionnaire-9 (PHQ-9) serves as a critical instrument for the screening, diagnosis, and assessment of depression, enabling the measurement of its severity.

  34. 7-item Generalized Anxiety Disorder Scale

    Time frame: From enrollment to the end of treatment at 3rd month

    A 7-item Generalized Anxiety Disorder Scale (GAD-7) was scored and collected. GAD-7 acts as an essential tool for evaluating generalized anxiety disorder

  35. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: From enrollment to the end of treatment at 3rd month

    The Pittsburgh Sleep Quality Index (PSQI)was scored and collected. the Pittsburgh Sleep Quality Index (PSQI) stands as a widely recognized assessment tool for determining sleep quality.

  36. Seattle Angina Questionnaire (SAQ)

    Time frame: From enrollment to the end of treatment at 3rd month

    The Seattle Angina Questionnaire (SAQ) was scored and collected. SAQ functions as a self-administered assessment tool designed to evaluate specific functional status and quality of life among individuals with coronary artery disease.

  37. Heart rate variability

    Time frame: From enrollment to the end of treatment at 3rd month

    Heart rate variability was scored and collected. Heart rate variability (HRV) refers to the fluctuation in the timing of consecutive heartbeats or the variance in heart rate. It is determined by the duration between two successive R-R intervals, representing the slight deviation between each cardiac cycle. HRV assessment was conducted using the ZSY-1 Rhythm Variability Analyzer, with the patient in a supine position, and short-term (5-minute) HRV was measured during daytime hours (8:00-16:00) while at rest.

Study contacts

Contact information is provided by the study sponsor or research team.

Chunwei He, MD

CONTACT

[email protected]

17361616499

Lin Shen, MD

CONTACT

[email protected]

18560082257

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

A Clinical Study of the Efficacy of Cardiovascular Ultrasound Therapy on the Rehabilitation of Patients After PCI for Coronary Artery Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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