Coronary Artery DiseaseSTRAIN-TIMINCT02831153
Evaluation of Emotional Status and Coronary Flow Characteristics by TIMI Frame Count Method
A study testing coronary angiography in people with Coronary Artery Disease and Coronary Artery Ectasia, run by Ertan YETKIN at 6 sites in Turkey (Türkiye).
Trial summary
This study evaluates the effects of emotional status on coronary flow in patients undergoing elective coronary angiography. Patients whom undergoing elective coronary angiography will fulfill the Beck Anxiety Inventory, Beck Depression Inventory, State-Trait Anxiety Inventory, Hospital Anxiety and Depression Scale. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Ectasia, Slow-Flow Phenomenon
- What is being tested?
- coronary angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- Jul 2016to Jul 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whom planned elective coronary angiography and accept to be included in the study as a participant
Who cannot join
- < 18 years, history of prior coronary angiography, history of coronary artery revascularization, acute coronary syndrome patients, atrial fibrillation, heart failure, known systemic diseases
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Turkey (Türkiye)6 sites, 4 recruiting
- Recruiting
Gulhane Military Medical Academy
Ankara, Kecioren
Turgay Celik, MD, 905326731032, benturgay@gmail.com
Turgay Celik, MD
- Recruiting
Ankara Numune Training and Research Hospital
Ankara
Mehmet Ileri, MD
maraspoli2020@gmail.com
- Active, not recruiting
Ankara Research and Training Hospital
Ankara
- Active, not recruiting
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara
- Recruiting
Private Gözde Hospital
Malatya
Izzet Tandogan, MD
Izzet Tandogan, MD
- Recruiting
Private Yenisehir Hospital
Mersin
Ertan Yetkin, MD, 905327136721, ertanyetkin@hotmail.com
Ertan Yetkin, MD
About this study
Official title: Effects of Emotional Status on Coronary Flow in Patients Undergoing Coronary Angiography:Multicenter TIMI Frame Count Assessment Study (STRAIN-TIMI Study)
This study evaluates the effects of emotional status on coronary flow in patients undergoing elective coronary angiography. Patients whom undergoing elective coronary angiography will fulfill the Beck Anxiety Inventory, Beck Depression Inventory, State-Trait Anxiety Inventory, Hospital Anxiety and Depression Scale. State Anxiety Inventory will be fulfilled both before the intervention and after 1 hour the patients learned the results of the coronary angiography. The other scales will be performed after 1 hour the patients learned their results. Coronary flow will be assessed by TIMI (Thrombolysis In Myocardial Infarction) frame count method.
- Conditions
- Coronary Artery Disease, Coronary Artery Ectasia, Slow-Flow Phenomenon, Endothelial Dysfunction, Anxiety, Depression
- Being tested
- coronary angiography
- Medical subject headings
- Coronary Artery Disease, Coronary Aneurysm, No-Reflow Phenomenon, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary angiographyProcedure or surgery
Coronary angiography will be performed by transfemoral or transradial approach in all patients. In order to evaluate each coronary artery, at least four views from the left and two views from the right system will be taken.
| Study group | Role | What they receive |
|---|---|---|
| normal coronary anatomy | Active comparator | coronary angiography will be performed by transfemoral or transradial route. Receives: Procedure: coronary angiography |
| coronary artery ectasia | Active comparator | coronary angiography will be performed by transfemoral or transradial route. Receives: Procedure: coronary angiography |
| slow coronary flow | Active comparator | coronary angiography will be performed by transfemoral or transradial route. Receives: Procedure: coronary angiography |
| nonobstructive coronary artery disease | Active comparator | coronary angiography will be performed by transfemoral or transradial route. Receives: Procedure: coronary angiography |
| obstructive coronary artery disease | Active comparator | coronary angiography will be performed by transfemoral or transradial route. Receives: Procedure: coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIMI frame count method analysis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ertan YETKIN
- Sponsor type
- University, hospital or other
- Collaborators
- Abant Izzet Baysal University, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi, Ankara City Hospital Bilkent, Private Yenisehir Hospital, Private Gozde Hospital, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Responsible party
- Sponsor-investigator, Ertan YETKIN, Vascular and Molecular Cardiology Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831153
- Sponsor's protocol ID
- Vasmol001
- Acronym
- STRAIN-TIMI
- Status last verified
- Jul 2016
- First submitted
- 10 Jul 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The results will be made available within 6 months of study completion
Publications
Ozturk S, Yalvac HD, Sivri N, Ozturk HM, Kilic Y, Bulut E, Celik A, Barlas Y, Tengiz I, Yetkin E. Anxiety and depression scores in patients with coronary artery disease and coronary artery ectasia. Int J Cardiol. 2015;186:299-301. doi: 10.1016/j.ijcard.2015.03.305. Epub 2015 Mar 20. No abstract available.
PubMed 25828141Yalvac D, Ozturk S, Sivri N, Kilic Y, Bulut E, Celik A, Barlas Y, Tengiz I, Yetkin E. Effects of patients anxiety and depression scores on coronary flow in patients with normal coronary arteries. Int J Cardiol. 2015 Feb 1;180:55-7. doi: 10.1016/j.ijcard.2014.11.153. Epub 2014 Nov 26. No abstract available.
PubMed 25438211Yetkin E, Waltenberger J. Novel insights into an old controversy: is coronary artery ectasia a variant of coronary atherosclerosis? Clin Res Cardiol. 2007 Jun;96(6):331-9. doi: 10.1007/s00392-007-0521-0. Epub 2007 Apr 26.
PubMed 17453130
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Emotional Status on Coronary Flow in Patients Undergoing Coronary Angiography:Multicenter TIMI Frame Count Assessment Study (STRAIN-TIMI Study)
- ClinicalTrials.gov ID
- NCT02831153
- Acronym / sponsor ID
- STRAIN-TIMI / Vasmol001
- Conditions
- Coronary Artery Disease, Coronary Artery Ectasia, Slow-Flow Phenomenon, Endothelial Dysfunction, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ertan YETKINUniversity, hospital or other
- Collaborators
- Abant Izzet Baysal University, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi, Ankara City Hospital Bilkent, Private Yenisehir Hospital, Private Gozde Hospital, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 13 Jul 2016 (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.
This study evaluates the effects of emotional status on coronary flow in patients undergoing elective coronary angiography. Patients whom undergoing elective coronary angiography will fulfill the Beck Anxiety Inventory, Beck Depression Inventory, State-Trait Anxiety Inventory, Hospital Anxiety and Depression Scale. State Anxiety Inventory will be fulfilled both before the intervention and after 1 hour the patients learned the results of the coronary angiography. The other scales will be performed after 1 hour the patients learned their results. Coronary flow will be assessed by TIMI (Thrombolysis In Myocardial Infarction) frame count method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| normal coronary anatomy | Active comparator | Procedure: coronary angiographycoronary angiography will be performed by transfemoral or transradial route. |
| coronary artery ectasia | Active comparator | Procedure: coronary angiographycoronary angiography will be performed by transfemoral or transradial route. |
| slow coronary flow | Active comparator | Procedure: coronary angiographycoronary angiography will be performed by transfemoral or transradial route. |
| nonobstructive coronary artery disease | Active comparator | Procedure: coronary angiographycoronary angiography will be performed by transfemoral or transradial route. |
| obstructive coronary artery disease | Active comparator | Procedure: coronary angiographycoronary angiography will be performed by transfemoral or transradial route. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients whom planned elective coronary angiography and accept to be included in the study as a participant
Key exclusion criteria (1 listed)
- < 18 years, history of prior coronary angiography, history of coronary artery revascularization, acute coronary syndrome patients, atrial fibrillation, heart failure, known systemic diseases
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 |
|---|---|---|
| coronary angiographyCoronary angiography will be performed by transfemoral or transradial approach in all patients. In order to evaluate each coronary artery, at least four views from the left and two views from the right system will be taken. | Procedure or surgery | coronary artery ectasia, nonobstructive coronary artery disease, normal coronary anatomy, obstructive coronary artery disease, slow coronary flow |
Primary outcome
TIMI frame count method analysis
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Background: PubMed 25828141Ozturk S, Yalvac HD, Sivri N, Ozturk HM, Kilic Y, Bulut E, Celik A, Barlas Y, Tengiz I, Yetkin E. Anxiety and depression scores in patients with coronary artery disease and coronary artery ectasia. Int J Cardiol. 2015;186:299-301. doi: 10.1016/j.ijcard.2015.03.305. Epub 2015 Mar 20. No abstract available.
- Background: PubMed 25438211Yalvac D, Ozturk S, Sivri N, Kilic Y, Bulut E, Celik A, Barlas Y, Tengiz I, Yetkin E. Effects of patients anxiety and depression scores on coronary flow in patients with normal coronary arteries. Int J Cardiol. 2015 Feb 1;180:55-7. doi: 10.1016/j.ijcard.2014.11.153. Epub 2014 Nov 26. No abstract available.
- Background: PubMed 17453130Yetkin E, Waltenberger J. Novel insights into an old controversy: is coronary artery ectasia a variant of coronary atherosclerosis? Clin Res Cardiol. 2007 Jun;96(6):331-9. doi: 10.1007/s00392-007-0521-0. Epub 2007 Apr 26.
- Individual participant dataSharing planned: Yes. The results will be made available within 6 months of study completion
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronary angiography in people with Coronary Artery Disease and Coronary Artery Ectasia, run by Ertan YETKIN at 6 sites in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ertan Yetkin, MD (905327136721, ertanyetkin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIMI frame count method analysis (time frame: 1 day). 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 NCT02831153, which also lists 3 linked publications.
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 13 Jul 2016.