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TherApy in stabLe Coronary Artery dIsease Patients According to Clinical GuideliNes (ALIGN)

N

National Research Center for Preventive Medicine

Status

Completed

Conditions

Stable Ischemic Heart Disease

Treatments

Behavioral: Patients with documented IHD

Study type

Observational

Funder types

Other

Identifiers

NCT04162561
PROFILE

Details and patient eligibility

About

The aim of this prospective cohort study is to assess the quality of therapy in patients with stable ischemic heart disease (IHD) who had never applied for specialized medical care for the last 3 years and try to accord their treatment with current clinical guidelines.

Full description

The purpose of this study is to assess the quality of therapy in patients having come for the first time consultation to the specialized cardiology department of the scientific research centre within the PROFILE registry and to try to correct therapy according to current clinical guidelines paying particular attention to reaching target blood pressure (BP), low-density lipoprotein cholesterol (LDL-C), glycosylated haemoglobin - HbA1c (in patients with diabetes mellitus) levels, improving exercise tolerance and quality of life.

The first visit (V0) is an inclusion in the study. During this visit, an attempt to correct or start (if it had not been started before) antiplatelet, hypolipidemic, antihypertensive and antianginal therapy will be made.

The second visit (V1) is planned for each patient three months after the first visit (V0). During the second visit number of patients who reached target levels of BP, LDL-C, frequency of angina attacks will be assessed. If necessary, correction of therapy will also be made.

The third visit (V2) is planned for each patient one year after the first visit (V0). During the third visit reaching target BP, LDL-C levels, frequency of angina attacks will be assessed. If necessary, therapy correction will be recommended.

The last visit - telephone contact with patients - is expected in 2 years after the first visit. During that visit it is planned to assess life status, complications and current medical treatment.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients with documented IHD having consequentially come for the first time for consultation to the specialized cardiology department of the scientific research center from December 31, 2017 to December 31, 2022.

Documented IHD:

  1. Positive results of the angina questionnaire (typical angina)

  2. Positive exercise electrocardiography or stress echocardiography, plus one of the following criteria:

    • ischemia documented by scintigraphy study
    • invasive coronary angiography data (stenosis of at least 75% in at least one main coronary artery)
    • previous coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG))
    • previous myocardial infarction
    • patients who had elective PCI or CABG

Exclusion criteria

  • Patients with acute IHD (less than 30 days since the last ischemic event with or without invasive procedures for the treatment of the event)
  • Patients' refuse to follow the study's graphic of doctors' visits

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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