AnginaNCT02065102
Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty
An observational study of Angina, run by Royal Infirmary of Edinburgh at 1 site in United Kingdom.
Trial summary
Coronary artery stenting has evolved as an effective treatment for angina and involves stretching up narrowings within the heart arteries using a balloon (coronary angioplasty) before implanting a small metal scaffold (stent) to splint the artery open. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing percutaneous coronary intervention requiring rotational atherectomy and coronary stent implantation in South East Scotland.
Who may be able to join
- Patients undergoing percutaneous coronary intervention requiring rotational atherectomy and coronary stent implantation for calcified coronary artery disease.
- Ability to give informed consent.
Who cannot join
- Inability to provide informed consent.
- Acute myocardial infarction.
- Cardiogenic shock.
- Renal failure (eGFR <30 mL/min) in patients who are not on dialysis.
- Pregnancy.
- Contrast allergy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA
About this study
Coronary artery stenting has evolved as an effective treatment for angina and involves stretching up narrowings within the heart arteries using a balloon (coronary angioplasty) before implanting a small metal scaffold (stent) to splint the artery open. It is imperative that stents are fully expanded when they are deployed. If not, then patients are exposed to the serious risk of a blood clot forming in the stent (stent thrombosis), or the stent renarrowing (restenosis). One fifth of patients experiencing stent thrombosis will die and 70% will suffer a heart attack. Restenosis is associated with recurrent angina and heart attacks.
Arguably, visualising stents and ensuring adequate stent expansion is most challenging in patients with extensive hardening, or calcification, of the heart arteries. Optical coherence tomography is a novel technique that utilises near-infrared light to look inside small blood vessels in fine detail. It is 10 times more powerful than the best existing technique, intravascular ultrasound.
The purpose of this study is to compare the utility of optical coherence tomography with intravascular ultrasound in patients with heavily calcified heart arteries undergoing rotational atherectomy and coronary stent insertion. It is hoped that the results of this pilot study will provide proof-of-principle and justification for a larger clinical trial to formally assess the role of optical coherence tomography to guide coronary angioplasty and stenting in patients with heavily calcified coronary arteries.
Read the detailed description
Twelve patients undergoing rotational atherectomy and coronary stenting for angina in Lothian will be recruited. Rotational atherectomy and stent implantation will be performed as part of routine clinical care. Immediately following stent implantation paired intravascular images of the implanted stent will be obtained using both intravascular ultrasound and optical coherence tomography. The stent will then be further dilated at high pressure with a non compliant balloon and the intravascular images repeated with both intravascular ultrasound and optical coherence tomography. The images obtained will be available to the operator to guide further treatment.
- Conditions
- Angina
- Keywords
- Rotational atherectomy, Angina, Optical coherence tomography, Intravascular ultrasound, Coronary stent
- Medical subject headings
- Angina Pectoris
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent malposition expressed as % of total stent area
The amount of stent not in direct contact with the blood vessel wall (malposition) expressed as a % of total stent area.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startNov 2012
- Primary completionMar 2014
- Study completionMar 2014
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 AnginaStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Infirmary of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Cruden, Royal Infirmary of Edinburgh
- Investigators
- Nicholas L Cruden, MBChB PhD, Principal investigator, Royal Infirmary of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065102
- Sponsor's protocol ID
- 12/R/CAR/13
- Status last verified
- Mar 2014
- First submitted
- 12 Feb 2014
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gudmundsdottir I, Adamson P, Gray C, Spratt JC, Behan MW, Henriksen P, Newby DE, Mills N, Uren NG, Cruden NL. Optical coherence tomography versus intravascular ultrasound to evaluate stent implantation in patients with calcific coronary artery disease. Open Heart. 2015 Dec 22;2(1):e000225. doi: 10.1136/openhrt-2014-000225. eCollection 2015.
PubMed 26719807
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty
- ClinicalTrials.gov ID
- NCT02065102
- Acronym / sponsor ID
- 12/R/CAR/13
- Conditions
- Angina
- Keywords
- Rotational atherectomy, Angina, Optical coherence tomography, Intravascular ultrasound, Coronary stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Royal Infirmary of EdinburghUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Feb 2014 (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.
Coronary artery stenting has evolved as an effective treatment for angina and involves stretching up narrowings within the heart arteries using a balloon (coronary angioplasty) before implanting a small metal scaffold (stent) to splint the artery open. It is imperative that stents are fully expanded when they are deployed. If not, then patients are exposed to the serious risk of a blood clot forming in the stent (stent thrombosis), or the stent renarrowing (restenosis). One fifth of patients experiencing stent thrombosis will die and 70% will suffer a heart attack. Restenosis is associated with recurrent angina and heart attacks.
Arguably, visualising stents and ensuring adequate stent expansion is most challenging in patients with extensive hardening, or calcification, of the heart arteries. Optical coherence tomography is a novel technique that utilises near-infrared light to look inside small blood vessels in fine detail. It is 10 times more powerful than the best existing technique, intravascular ultrasound.
The purpose of this study is to compare the utility of optical coherence tomography with intravascular ultrasound in patients with heavily calcified heart arteries undergoing rotational atherectomy and coronary stent insertion. It is hoped that the results of this pilot study will provide proof-of-principle and justification for a larger clinical trial to formally assess the role of optical coherence tomography to guide coronary angioplasty and stenting in patients with heavily calcified coronary arteries.
Detailed description
Twelve patients undergoing rotational atherectomy and coronary stenting for angina in Lothian will be recruited. Rotational atherectomy and stent implantation will be performed as part of routine clinical care. Immediately following stent implantation paired intravascular images of the implanted stent will be obtained using both intravascular ultrasound and optical coherence tomography. The stent will then be further dilated at high pressure with a non compliant balloon and the intravascular images repeated with both intravascular ultrasound and optical coherence tomography. The images obtained will be available to the operator to guide further treatment.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing percutaneous coronary intervention requiring rotational atherectomy and coronary stent implantation in South East Scotland.
Key inclusion criteria (2 listed)
- Patients undergoing percutaneous coronary intervention requiring rotational atherectomy and coronary stent implantation for calcified coronary artery disease.
- Ability to give informed consent.
Key exclusion criteria (6 listed)
- Inability to provide informed consent.
- Acute myocardial infarction.
- Cardiogenic shock.
- Renal failure (eGFR <30 mL/min) in patients who are not on dialysis.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stent malposition expressed as % of total stent area
Time frame: Day 1
The amount of stent not in direct contact with the blood vessel wall (malposition) expressed as a % of total stent area.
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 6 Mar 2014.
- Derived from this study: PubMed 26719807Gudmundsdottir I, Adamson P, Gray C, Spratt JC, Behan MW, Henriksen P, Newby DE, Mills N, Uren NG, Cruden NL. Optical coherence tomography versus intravascular ultrasound to evaluate stent implantation in patients with calcific coronary artery disease. Open Heart. 2015 Dec 22;2(1):e000225. doi: 10.1136/openhrt-2014-000225. eCollection 2015.
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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.
Nicholas L Cruden, MBChB PhD principal investigator
Royal Infirmary of Edinburgh
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 Angina, run by Royal Infirmary of Edinburgh at 1 site in United Kingdom.
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 2 inclusion and 6 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 6 Mar 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 United Kingdom. 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?
Stent malposition expressed as % of total stent area (time frame: Day 1). 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 NCT02065102, 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 6 Mar 2014.