Coronary AngiographyTCCT-TIMINCT02818127
Assessment Of Total Coronary Circulation Time Using TIMI Frame Count Method (TCCT-TIMI)
A study testing coronary angiography in people with Coronary Angiography and Coronary Artery Disease, run by Vascular and Molecular Cardiology Society at 3 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate and describe the total coronary circulation time (TCCT) by using TIMI frame count method in patients performed coronary angiography. TCCT is described as an angiographic index which is the sum of the frame count of coronary artery and venous system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography, Coronary Artery Disease, Coronary Artery Ectasia
- 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
- 3 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 performed coronary angiography with a suspicion of coronary artery disease
Who cannot join
- History of cerebrovascular disease, chronic inflamatuar disease, malignity, chronic kidney and hepatic disease
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Gulhane Military Medical Academy
Ankara, Kecioren
Turgay Celik, MD, 905326731032, benturgay@gmail.com
Turgay Celik, MD
- Recruiting
Private Gozde 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: Assessment Of Total Coronary Circulation Time Using TIMI Frame Count Method In Patients Undergoing Coronary Angiography
The aim of this study is to evaluate and describe the total coronary circulation time (TCCT) by using TIMI frame count method in patients performed coronary angiography. TCCT is described as an angiographic index which is the sum of the frame count of coronary artery and venous system. This study also evaluates the relationship between the diseases in arterial system such as coronary artery ectasia, coronary slow flow, coronary artery disease and coronary venous pathologies.
- Conditions
- Coronary Angiography, Coronary Artery Disease, Coronary Artery Ectasia, Slow-Flow Phenomenon, Coronary Heart Disease
- Being tested
- coronary angiography
- Medical subject headings
- Coronary Artery Disease, Coronary Aneurysm, No-Reflow Phenomenon, Coronary Disease
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 artery | Active comparator | coronary angiography will be performed by transfemoral or transradial route. Receives: Procedure: coronary angiography |
| coronary slow flow | 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 |
| non-obstructive 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.
Evaluation of total coronary circulation time by using TIMI frame count method
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 posted29 Jun 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 (2)Papers the sponsor has linked to this study.
- Other trials for Coronary AngiographyStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascular and Molecular Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Private Yenisehir Hospital, Private Gozde Hospital, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818127
- Sponsor's protocol ID
- Vasmol002
- Acronym
- TCCT-TIMI
- Status last verified
- Jul 2016
- First submitted
- 27 Jun 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
von Ludinghausen M. The venous drainage of the human myocardium. Adv Anat Embryol Cell Biol. 2003;168:I-VIII, 1-104. doi: 10.1007/978-3-642-55623-4.
PubMed 12645157Gibson CM, Cannon CP, Daley WL, Dodge JT Jr, Alexander B Jr, Marble SJ, McCabe CH, Raymond L, Fortin T, Poole WK, Braunwald E. TIMI frame count: a quantitative method of assessing coronary artery flow. Circulation. 1996 Mar 1;93(5):879-88. doi: 10.1161/01.cir.93.5.879.
PubMed 8598078
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Total Coronary Circulation Time Using TIMI Frame Count Method In Patients Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT02818127
- Acronym / sponsor ID
- TCCT-TIMI / Vasmol002
- Conditions
- Coronary Angiography, Coronary Artery Disease, Coronary Artery Ectasia, Slow-Flow Phenomenon, Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Vascular and Molecular Cardiology SocietyUniversity, hospital or other
- Collaborators
- Private Yenisehir Hospital, Private Gozde Hospital, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 29 Jun 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.
The aim of this study is to evaluate and describe the total coronary circulation time (TCCT) by using TIMI frame count method in patients performed coronary angiography. TCCT is described as an angiographic index which is the sum of the frame count of coronary artery and venous system. This study also evaluates the relationship between the diseases in arterial system such as coronary artery ectasia, coronary slow flow, coronary artery disease and coronary venous pathologies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| normal coronary artery | Active comparator | Procedure: coronary angiographycoronary angiography will be performed by transfemoral or transradial route. |
| coronary slow flow | 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. |
| non-obstructive 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 performed coronary angiography with a suspicion of coronary artery disease
Key exclusion criteria (1 listed)
- History of cerebrovascular disease, chronic inflamatuar disease, malignity, chronic kidney and hepatic 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 |
|---|---|---|
| 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, coronary slow flow, non-obstructive coronary artery disease, normal coronary artery, obstructive coronary artery disease |
Primary outcome
Evaluation of total coronary circulation time by using TIMI frame count method
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 12 Jul 2016.
- Background: PubMed 12645157von Ludinghausen M. The venous drainage of the human myocardium. Adv Anat Embryol Cell Biol. 2003;168:I-VIII, 1-104. doi: 10.1007/978-3-642-55623-4.
- Background: PubMed 8598078Gibson CM, Cannon CP, Daley WL, Dodge JT Jr, Alexander B Jr, Marble SJ, McCabe CH, Raymond L, Fortin T, Poole WK, Braunwald E. TIMI frame count: a quantitative method of assessing coronary artery flow. Circulation. 1996 Mar 1;93(5):879-88. doi: 10.1161/01.cir.93.5.879.
- Individual participant dataSharing planned: Yes
Related trials for Coronary Angiography
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
Not yet recruiting
Cardiac CT Angiography in Acute Stroke Imaging (SCOPE-CT)
Acute Ischemic Stroke and Transient Ischemic Attacks
Recruiting
CCTA-Based vs CAG-Based CABG: A Multicenter Pragmatic Non-Inferiority Trial
Coronary Artery Disease, Coronary Artery Bypass Grafting
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.
3 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 Angiography and Coronary Artery Disease, run by Vascular and Molecular Cardiology Society at 3 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 12 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 3 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?
Evaluation of total coronary circulation time by using TIMI frame count method (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 NCT02818127, which also lists 2 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 12 Jul 2016.