The Influence of Cardiac Rehabilitation on the Health State After ACS

NCT03935438 | Unknown

• 1 other identifier: 476/19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary heart disease, including acute coronary syndromes (ACS), is the leading cause of death in European countries. One of the basic elements of secondary and tertiary prevention of ACS is cardiac rehabilitation. The aims of the study are evaluation of the impact of cardiac rehabilitation on health state- especially on cardiovascular function parameters in patients after acute coronary syndrome and evaluation of the influence of the level of gene expression and polymorphisms of genes associated with ischemic heart disease on the course of cardiac rehabilitation in patients after ACS. The study will consist of a retrospective and prospective part. The retrospective part will include patients who have had acute coronary syndrome in the past and then - before being included in the study - have undergone cardiac rehabilitation. In the retrospective part, patients enrolled in the study will not undergo cardiac rehabilitation as a part of the study intervention. The prospective part will include patients who have had an acute coronary syndrome in the past and will undergo cardiac rehabilitation as the study intervention. After being included in the study, patients will undergo medical examination. Then subsequent procedures will be performed: anthropometric measurements; ECG; body composition analysis by bioimpedance; measurement of resting blood pressure, resting heart rate and oxygen saturation of hemoglobin; pulse wave analysis; transthoracic echocardiography of the heart; 24-hour blood pressure measurement by ambulatory blood pressure monitoring (ABPM); 24-hour ECG recording using the Holter method; electrocardiographic exercise test on a treadmill and / or a six-minute walk test or other exercise test adequate to the patient's state of health; assessment of the quality of the diet; assessment of lifestyle, acceptance of disease and quality of life; assessment of the psychological profile. Subsequently patients taking part in the prospective part of the study will perform a cardiac rehabilitation program. After the cardiac rehabilitation program measurement procedures listed above will be repeated. Before and after the cardiac rehabilitation program blood samples, urine samples and hair samples will be collected. Blood samples, urine samples and hair samples will also be collected from patients taking part in the retrospective part of the study.

Conditions

Cardiac Rehabilitation; Acute Coronary Syndrome

Keywords

cardiac rehabilitation; acute coronary syndrome; anthropometric parameters; physical efficiency; cardiovascular function

Outcome Measures

Primary Outcomes (2)

• Pulse wave velocity (PWV) I

  Pulse wave velocity I

  At baseline

• PWV II

  Pulse wave velocity II

  After intervention completion- an average of 2 weeks from baseline

Secondary Outcomes (89)

• Aortic pressure (AP) I

  At baseline

• AP II

  After intervention completion- an average of 2 weeks from baseline

• Body mass (BM) I

  At baseline

• BM II

  After intervention completion- an average of 2 weeks from baseline

• Body height (BH) I

  At baseline

Study Arms (1)

Patients after ACS

EXPERIMENTAL

Patients after acute coronary syndrome undergoing cardiac rehabilitation.

Other: Cardiac rehabilitation

Interventions

Cardiac rehabilitation OTHER

The training program of cardiac rehabilitation, depending on the results of the patient's medical qualification, will consist of the following: free active exercises, isometric exercises, active exercises in relief with resistance, isotonic exercises, isokinetic exercises, active breathing exercises, active breathing exercises with resistance, balance exercises, general exercises- individual and in groups, interval training on a treadmill or cycling cycloergometer, continuous training on a treadmill or cycling cycloergometer, circuit training, walking training, march training with accessories, autogenic training, walking. The training program will last an average 2 weeks.

Patients after ACS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent in writing
• Coronary heart disease, a state after an acute coronary syndrome
• Female or male
• Age 18 - 99 years

You may not qualify if:

• Active neoplastic disease
• Alcohol abuse, drug abuse
• Pregnancy, lactation
• Other conditions that in the opinion of researchers may pose any risk to the patient during the study.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences

Poznan, Wielkopolska, 60-569, Poland

RECRUITING

Related Publications (2)

• Skrypnik D, Skrypnik K, Granell JC, Woszczyk D, Suliburska J. Cardiac rehabilitation influences serum myokine levels in patients after acute coronary syndrome: the randomised CARDIO-REH study. Sci Rep. 2025 Nov 6;15(1):38951. doi: 10.1038/s41598-025-22897-0.

  PMID: 41198895 DERIVED

• Skrypnik D, Skrypnik K, Suliburska J, Bogdanski P. Cardiac rehabilitation may influence leptin and VEGF A crosstalk in patients after acute coronary syndrome. Sci Rep. 2022 Jul 12;12(1):11825. doi: 10.1038/s41598-022-16053-1.

  PMID: 35821400 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Damian Skrypnik, MD; PhD

  Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damian Skrypnik, MD; PhD

CONTACT

+48798394812; damian.skrypnik@gmail.com

Paweł Bogdański, Prof.

CONTACT

+48502335001; pawelbogdanski73@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Study Manager; Doctor of Medicine

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 2, 2019
• Study Start: April 12, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)