Clinical trial NCT04491760: Inspiratory Muscle Training in Patients With Acute Myocardial Infarction
Official title: Feasibility of Inspiratory Muscle Training in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention and Complicated With High Risk of Pneumonia: a Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pneumonia is uncommon high among patients with acute myocardial infarction (AMI), which increases adverse clinical events and prolongs the hospital stay. Inspiratory muscle training (IMT) is able to improve inspiratory muscle strength and prevent pneumonia in patients undergoing cardiac surgery including coronary artery bypass grafting. Thus, the investigators design the study mainly aim to evaluate the 30 days IMT for the change of inspiratory muscle strength, and also to observe its potentially effect on reducing pneumonia, in participants who accepted primary percutaneous coronary intervention (PCI) and at a high risk of pneumonia.

Detailed description: This is a single center, prospective, randomized controlled study. All participants will be followed up until 30 days after randomized.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years, patients with AMI undergoing primary PCI, admitted to cardiac intensive care unit and at a high pneumonia risk \[2 or more of the following parameters are regarded as high risk for pneumonia: 1. Age \> 55 years, 2. Diabetes mellitus, 3. Smoking at present, 4. Chronic kidney disease: estimated glomerular filtration rate \< 60 mL/min/1.73m2, 5. Forced expiratory volume in the first second of expiration (FEV1) \< 80% predicted and FEV1/forced vital capacity (FVC) \< 70% predicted\]
* be able to understand and agree with informed consent

Exclusion Criteria:

* a history of cerebrovascular accident
* treat with immunosuppressive medication for 30 days before
* neuromuscular disorder
* cardiovascular instability (such as aortic dissection or unstable hemodynamics)
* a history of Coronary Artery Bypass Grafting (CABG)
* expected survival is less than 6 months due to noncardiogenic disease
* participated in other drugs and devices studies within 30 days
* confirmed as ventricular aneurysm
* other conditions not suit for the study after the discussion among the researchers (eg: poor compliance, unable to cooperate for the training)

Primary outcomes:
measure: Change in inspiratory muscle strength
timeFrame: at baseline, at 30 days
Secondary outcomes:
measure: Pneumonia
timeFrame: up to 30 days
measure: Major adverse cardiovascular events (MACE)
timeFrame: up to 30 days
measure: Vital signs of participants during training
timeFrame: up to 30 days
measure: Satisfactory assessment
timeFrame: up to 30 days
measure: Length of stay
timeFrame: up to 120 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital, Guangzhou, China.
name: Yuanhui Liu, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
citation: Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
citation: American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
citation: Liu Y, Dai Y, Liu Z, Zhan H, Zhu M, Chen X, Zhang S, Zhang G, Xue L, Duan C, Chen J, Guo L, He P, Tan N. The Safety and Efficacy of Inspiratory Muscle Training for Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention: Study Protocol for a Randomized Controlled Trial. Front Cardiovasc Med. 2021 Jan 12;7:598054. doi: 10.3389/fcvm.2020.598054. eCollection 2020.