FMDTCANCT01862146
Arterial Remodeling in Smokers
An observational study of FMD and IMT, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial summary
Cigarette smoking is the most important modifiable cardiovascular risk factor leading to endothelial dysfunction and was suggested to impair arterial regeneration.The aim of the study was to investigate the effect of smoking on vascular response to transradial coronary angiography (TCA). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- What is being tested?
- smoke expose
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Jun 2014
- Phase
- Observational
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all subjects who underwent an TCA (trans radial catheterisation)
Who may be able to join
- all subjects underwent a TCA
Who cannot join
- acute inflammation cardiac arrhythmia renal failure heart failure (NYHA II-IV) CRP > 1 mg/dl malignant disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Response-to-injury in Patients Undergoing Transradial Coronary Angiography: Arterial Remodeling in Smokers
Cigarette smoking is the most important modifiable cardiovascular risk factor leading to endothelial dysfunction and was suggested to impair arterial regeneration.The aim of the study was to investigate the effect of smoking on vascular response to transradial coronary angiography (TCA).
- Being tested
- smoke expose
- Keywords
- TCA, FMD, IMT, Smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoke exposeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Current Smoker underwent TCA | subjects who smokes daily Receives: Procedure: smoke expose | |
| Former Smokers underwent TCA | subjects who do not smoke since 7 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMT hyperplasia
IMT is measured by high resolution ultrasound in the radial arteries.
Measured: change in radials IMT after 6-14 month after a TCA
Secondary outcomes (1)
Endothelial function
Flow mediated dilatation (FMD)
Measured: change in flow mediated dilatation after 10-14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FMDStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Christian Heiss, MD, Principal investigator, Division of Cardiology, Pulmonology and Vascular MedicineMalte Kelm, MD, Study chair, Division of Cardiology, Pulmonology and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862146
- Sponsor's protocol ID
- TCA INJURY
- Acronym
- TCA
- Status last verified
- Jun 2014
- First submitted
- 22 May 2013
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response-to-injury in Patients Undergoing Transradial Coronary Angiography: Arterial Remodeling in Smokers
- ClinicalTrials.gov ID
- NCT01862146
- Acronym / sponsor ID
- TCA / TCA INJURY
- Keywords
- TCA, FMD, IMT, Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 May 2013 (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.
Cigarette smoking is the most important modifiable cardiovascular risk factor leading to endothelial dysfunction and was suggested to impair arterial regeneration.The aim of the study was to investigate the effect of smoking on vascular response to transradial coronary angiography (TCA).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current Smoker underwent TCA | – | Procedure: smoke exposesubjects who smokes daily |
| Former Smokers underwent TCA | – | –subjects who do not smoke since 7 years |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all subjects who underwent an TCA (trans radial catheterisation)
Key inclusion criteria (1 listed)
- all subjects underwent a TCA
Key exclusion criteria (1 listed)
- acute inflammation cardiac arrhythmia renal failure heart failure (NYHA II-IV) CRP > 1 mg/dl malignant disease
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 |
|---|---|---|
| smoke expose | Procedure or surgery | Current Smoker underwent TCA |
Primary outcome
IMT hyperplasia
Time frame: change in radials IMT after 6-14 month after a TCA
IMT is measured by high resolution ultrasound in the radial arteries.
1 secondary outcome
Endothelial function
Time frame: change in flow mediated dilatation after 10-14 months
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 4 Jun 2014.
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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.
Christian Heiss, MD principal investigator
Division of Cardiology, Pulmonology and Vascular Medicine
Malte Kelm, MD study chair
Division of Cardiology, Pulmonology and Vascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of FMD and IMT, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
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 1 inclusion and 1 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 4 Jun 2014. 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 Germany. 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?
IMT hyperplasia (time frame: change in radials IMT after 6-14 month after a TCA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2014.