Myocardial InfarctionNCT01474408
Venous Function in Cardiovascular Disease Patients
A study testing interval training day 1 and Moderate exercise day 2 in people with Myocardial Infarction, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The primary aim is to determine the acute effect of two different training interventions on venous plasticity in patients with myocardial infarction (MI), revascularization or coronary artery graft surgery compared to age-matched healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- interval training day 1 and Moderate exercise day 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- myocardial infraction (MI)
- revascularization (PCI)
- coronary artery bypass graft surgery (CABG)
Who cannot join
- unstable angina pectoris
- uncontrolled hypertension
- orthopedic and/or neurological limitations
- participation in other studies
- MI (closer than 4 weeks)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Venous Function in Cardiovascular Disease Patients; The Neglected Part of Circulatory Regulation
The primary aim is to determine the acute effect of two different training interventions on venous plasticity in patients with myocardial infarction (MI), revascularization or coronary artery graft surgery compared to age-matched healthy subjects.
Read the detailed description
Compare the effect of 4 x 4 minutes at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate and moderate continuous exercise at 70 % of peak heart rate on venous function.
- Conditions
- Myocardial Infarction
- Being tested
- interval training day 1, Moderate exercise day 2, Control day 3
- Keywords
- Coronary artery bypass, Exercise therapy, Revascularization (PCI)
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interval training day 1Behavioural
Also called aerobic interval training
Moderate exercise day 2Behavioural
Control day 3Behavioural
| Study group | Role | What they receive |
|---|---|---|
| interval training | Experimental | 4 x 4 minutes exercise at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate Receives: Behavioral: interval training day 1; Behavioral: Moderate exercise day 2; Behavioral: Control day 3 |
| moderate exercise | Active comparator | moderate continuous exercise at 70 % of peak heart rate on venous function. Receives: Behavioral: interval training day 1; Behavioral: Moderate exercise day 2; Behavioral: Control day 3 |
| control | Other | routine measurements, no exercise Receives: Behavioral: interval training day 1; Behavioral: Moderate exercise day 2; Behavioral: Control day 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous Compliance change
Measured by echocardiography
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrik Wisløff, prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474408
- Sponsor's protocol ID
- 2011/760
- Status last verified
- Feb 2017
- First submitted
- 4 Nov 2011
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Leinan IM, Aamot IL, Stoylen A, Karlsen T, Wisloff U. Upper arm venous compliance and fitness in stable coronary artery disease patients and healthy controls. Clin Physiol Funct Imaging. 2017 Sep;37(5):498-506. doi: 10.1111/cpf.12324. Epub 2015 Dec 15.
PubMed 26667796
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Function in Cardiovascular Disease Patients; The Neglected Part of Circulatory Regulation
- ClinicalTrials.gov ID
- NCT01474408
- Acronym / sponsor ID
- 2011/760
- Conditions
- Myocardial Infarction
- Keywords
- Coronary artery bypass, Exercise therapy, Revascularization (PCI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim is to determine the acute effect of two different training interventions on venous plasticity in patients with myocardial infarction (MI), revascularization or coronary artery graft surgery compared to age-matched healthy subjects.
Detailed description
Compare the effect of 4 x 4 minutes at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate and moderate continuous exercise at 70 % of peak heart rate on venous function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| interval training | Experimental | Behavioral: interval training day 1, Behavioral: Moderate exercise day 2, Behavioral: Control day 34 x 4 minutes exercise at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate |
| moderate exercise | Active comparator | Behavioral: interval training day 1, Behavioral: Moderate exercise day 2, Behavioral: Control day 3moderate continuous exercise at 70 % of peak heart rate on venous function. |
| control | Other | Behavioral: interval training day 1, Behavioral: Moderate exercise day 2, Behavioral: Control day 3routine measurements, no exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- myocardial infraction (MI)
- revascularization (PCI)
- coronary artery bypass graft surgery (CABG)
Key exclusion criteria (5 listed)
- unstable angina pectoris
- uncontrolled hypertension
- orthopedic and/or neurological limitations
- participation in other studies
- MI (closer than 4 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interval training day 1Also: aerobic interval training | Behavioural | control, interval training, moderate exercise |
| Moderate exercise day 2 | Behavioural | control, interval training, moderate exercise |
| Control day 3 | Behavioural | control, interval training, moderate exercise |
Primary outcome
Venous Compliance change
Time frame: 48 hours
Measured by echocardiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Results publication: PubMed 26667796Leinan IM, Aamot IL, Stoylen A, Karlsen T, Wisloff U. Upper arm venous compliance and fitness in stable coronary artery disease patients and healthy controls. Clin Physiol Funct Imaging. 2017 Sep;37(5):498-506. doi: 10.1111/cpf.12324. Epub 2015 Dec 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrik Wisløff, prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interval training day 1 and Moderate exercise day 2 in people with Myocardial Infarction, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous Compliance change (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01474408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.