Clinical trial NCT02713724: Effects of Personalized Training Program on Coronary Flow Reserve in Healthy Volunteers
Official title: Effects of a Personalized Training Program on Trans-thoracic Adenosine-assisted Coronary Flow Reserve in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Heart Infarction
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study investigates whether an individualized exercise program, including a personal trainer, can improve cardiovascular status quantified with ultrasound to assess coronary flow reserve and other non-invasive techniques. The subjects in the study will be divided into two groups; one group will have a personalized exercise- and nutrition program and the other group will have acess to a gym membership, but no personal trainer.

Detailed description: Coronary heart disease is one of our most common diseases that causes significant morbidity and mortality. Because the risk of serious cardiovascular events, such as myocardial infarction and death, is evident in this patient population, it is of utmost importance to develop diagnostic methods to identify patients at risk. The most appropriate diagnostic methods are those that are safe to implement for both patient and physician, but also accessible and cost-efficient.

By using non-invasive techniques such as ultrasound, coronary artery function can be examined as coronary flow reserve (CFR). In the platform of non-invasive techniques used by the investigators for examinations of cardiovascular status, other methods are included, such as measurement of intima-media thickness in the carotid and radial arteries. The investigators goal is to compare the group with the personalized program with its placebo, and to compare the two study-groups with each other, to investigate whether the personalized program provides greater health benefits.

Eligibility criteria: Inclusion Criteria:

* non-smokers
* no current medication,
* no known diseases that require regular medication
* no known risk factor for cardiovascular disease (hypertension, hyperlipidemia, diabetes, heredity, obesity, peripheral vascular disease)
* no physically fit athletes.

Exclusion Criteria:

* ongoing treatment with medicine containing dipyridamole (asasantin, persantin)
* known hypersensitivity to adenosine
* chronic obstructive pulmonary disease
* atrial fibrillation or other obvious arrythmias
* AV-block grade 2 or higher
* other serious illness

Primary outcomes:
measure: Coronary flow reserve (CFR)
timeFrame: 3-6 months
Secondary outcomes:
measure: endothelial function
timeFrame: 3-6 months
measure: cIMT (carotid artery intima-media thickness)
timeFrame: 3-6 months
measure: metabolic biomarkers
timeFrame: 3-6 months
measure: cardiovascular biomarkers
timeFrame: 3-6 months
measure: QoL (quality of life)
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: VG-region
Study officials:
affiliation: Göteborg University
name: Sara Svedlund, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Westergren HU, Gan LM, Mansson M, Svedlund S. Randomized clinical trial studying effects of a personalized supervised lifestyle intervention program on cardiovascular status in physically inactive healthy volunteers. Oncotarget. 2018 Jan 3;9(10):9498-9511. doi: 10.18632/oncotarget.23958. eCollection 2018 Feb 6.