Angina (Stable)CorMicA-PCINCT06854302
Angina After PCI: a Systems Medicine Study
An observational study of Angina (Stable) and Ischemic Heart Disease (IHD), run by NHS National Waiting Times Centre Board at 4 sites in United Kingdom.
Trial summary
Angina may persist or recur in patients treated by coronary angioplasty. The angioplasty involves a balloon treatment to open a blocked heart blood vessel and usually a stent (thin metal tube) is placed. Stents do not always improve symptoms and may make symptoms worse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina (Stable), Ischemic Heart Disease (IHD)
- What is being tested?
- Cardiovascular magnetic resonance imaging and Coronary physiology
- Type of treatment
- Injection or infusion
- How many people
- 600 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 17 Sep 2024to 1 Oct 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with stable angina in whom stress perfusion CMR imaging is reasonable on clinical and/or research grounds and in whom invasive management is plausible or intended will be eligible to participate.
Who may be able to join
- BEFORE INVASIVE MANGEMENT
- Angina by SAQ-7 Angina Frequency Score <90*
- Stress CMR imaging*
- DURING INVASIVE MANAGEMENT
- PCI (successful)
- Coronary physiology assessment post-PCI.
Who cannot join
- Age <=18 years
- Acute MI within 30 days
- Invasive management >90 days after stress CMR
- Inability to comply with the protocol
- Lack of written informed consent.
- Pregnancy.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom4 sites
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB20AY
Golden Jubilee National Hospital
Clydebank, Dunbartonshire, G814DY
University Hospital Hairmyres
East Kilbride, Lanarkshire, G75 8RG
Leeds General Infirmary
Leeds, Yorkshire, LS13EX
About this study
Official title: Angina After PCI: a Systems Medicine Cohort Study
Angina may persist or recur in patients treated by coronary angioplasty. The angioplasty involves a balloon treatment to open a blocked heart blood vessel and usually a stent (thin metal tube) is placed. Stents do not always improve symptoms and may make symptoms worse. Sometimes a drug-eluting-balloon is used instead of a stent.
This balloon coats the inside of the blood vessel to prevent re-narrowing. Research is needed to clarify the causes of ongoing angina and its impact on patients and the NHS, and to identify which patients will or will not benefit from a stent (hence avoiding over-treatment in the future).
Read more
We plan a 5-year UK-wide multicenter study involving up to 600 patients with angina undergoing coronary angioplasty (with or without a stent). They will initially have a heart MRI scan. We will assess what might influence the recurrence of angina in the year after the angioplasty procedure. We will measure small blood vessel function in the heart and the amount of plaque persisting after PCI.
Patients who report angina after coronary angioplasty usually have a second invasive angiogram. Instead, we will invite patients to have a heart MRI scan allowing us to also assess whether this scan might be more useful than a repeat angiogram in guiding clinical care. We will collaborate with life scientists, mathematicians, statisticians, and health economists to better understand causes and health economic implications of angina arising after coronary angioplasty procedures.
Read the detailed description
Background: Prior studies indicate that potentially one in three patients may experience angina within 12 months of undergoing percutaneous coronary intervention (PCI).
Hypothesis: 1) Diffuse coronary atherosclerosis and/or microvascular dysfunction impair myocardial blood flow (MBF) leading to angina post-PCI.
Design: A 5-year interdisciplinary program with 3 scientific work-packages (WPs): 1) Clinical, 2) Systems medicine, and 3) Health Economics.
WP1) Cohort study In 4 or more centers in the United Kingdom, 600 patients with angina will undergo stress/rest perfusion cardiovascular magnetic resonance (CMR) imaging with inline pixel-mapping of MBF (ml/min/g) and then coronary physiology measured during PCI. Patient reported outcome measures will be collected routinely during follow-up to 12 months.
Primary outcome: Adjudicated, residual angina (Seattle Angina Questionnaire Angina Frequency (SAQ-7-AF) score <90).
Nested case-control study: stress perfusion CMR (MBF culprit artery territory, primary outcome) in approximately 200 patients reporting residual angina and 50 consecutive asymptomatic controls (all post-PCI). Clinically indicated coronary angiography including physiology tests (change from baseline measurement) and acetylcholine testing will be undertaken in approximately 120 patients.
WP2) Systems medicine (n=600) using biostatistics to identify multivariable baseline associates (clinical, coronary physiology, haemodynamics, circulating biomarkers (DNA, RNA, protein) of the SAQ-7-AF score (range 0 (Severe) - 100 (no angina)) post-PCI.
WP3) Health economics of NHS resource utilization and value of information (VoI) modelling to design stratified medicine trials.
Value: Identification of mechanisms to inform downstream diagnostic and therapeutic strategies for angina post-PCI.
- Conditions
- Angina (Stable), Ischemic Heart Disease (IHD)
- Being tested
- Cardiovascular magnetic resonance imaging, Coronary physiology
- Keywords
- Angina, Microvascular angina, Percutaneous coronary intervention, Systems medicine, Health economics, cohort study, coronary artery disease, Cardiovascular magnetic resonance imaging, Coronary physiology, Health-related quality of life, Clinical outcomes
- Medical subject headings
- Angina, Stable, Myocardial Ischemia, Angina Pectoris, Microvascular Angina, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular magnetic resonance imagingDiagnostic test
Observational diagnostic tests will include adenosine-stress perfusion cardiovascular magnetic resonance imaging before undergoing percutaneous coronary intervention.
Coronary physiologyDiagnostic test
Invasive coronary function tests using a diagnostic guidewire (PressureWire-X, Abbott), thermodilution, intravenous or intracoronary infusion of adenosine and intracoronary infusions of acetylcholine.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving percutaneous coronary intervention | The study population will include individuals with stable angina who undergo stress perfusion cardiovascular magnetic resonance (CMR) imaging before invasive management.
Eligibility will be sequentially assessed. Informed consent will initially be based on angina occurring in patients in whom there is a reasonable expectation for invasive management. Stress CMR imaging should be undertaken on either clinical grounds or for research. Potentially, 700 patients will provide written informed consent. Finally, eligibility will be reassessed during invasive management and eligibility will be confirmed when percutaneous coronary intervention is completed.
The population will be defined by individuals who fulfil the eligibility criteria. The target sample size is 600 patients with complete data post-PCI. This sample size is anticipated to lead to approximately 200 participants who will report angina consistent with an Seattle Angina Questionnaire Angina Frequency score <90. Receives: Diagnostic Test: Cardiovascular magnetic resonance imaging; Diagnostic Test: Coronary physiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual angina after percutaneous coronary intervention.
Residual angina post-PCI, defined as adjudicated, angina (Seattle Angina Questionnaire Angina Frequency (SAQ-7-AF) score <90) occurring within one year of percutaneous coronary intervention.
Measured: From enrolment to 12 months
Secondary outcomes (14)
Angina
Angina severity will be assessed using the Seattle Angina Questionnaire Summary Score.
Measured: From enrolment to 12 months
Myocardial perfusion reserve
Myocardial perfusion reserve (MPR) within the distribution of the target coronary artery/ies revealed by cardiovascular magnetic resonance (CMR) imaging.
Measured: From enrolment to 12 months
Fractional flow reserve post-percutaneous coronary intervention
Fractional flow reserve after percutaneous coronary intervention, reflecting the success of the procedure.
Measured: 24 hours
Coronary flow reserve after percutaneous coronary intervention
Coronary flow reserve (CFR) post-PCI. Coronary flow reserve takes account of adenosine-mediated vasodilatation of the coronary artery and microcirculation. A CFR <2.0 is abnormal, a CFR 2.0-<2.5 is impaired and a CFR>2.5 is normal.
Measured: 24 hours
Index of microvascular resistance after percutaneous coronary intervention
Index of microvascular resistance (IMR) post-PCI. IMR reflects adenosine-mediated minimal microvascular resistance. An IMR >=25 is abnormal.
Measured: 24 hours
Microvascular dysfunction after percutaneous coronary intervention
Microvascular dysfunction is defined as a CFR<2.5 and/or an IMR>=25 post-PCI.
Measured: 24 hours
Health-related quality of life
Health-related quality of life will be assessed using the EuroQol-5D 5 Level (5L) questionnaire. EQ-5D-5L is a health status questionnaire that measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Measured: From enrolment to 12 months
Physical function
The Duke Activity Status Index (DASI) is a self-administered questionnaire with a 12-item scale that estimates physical functional capacity, cardiorespiratory function and metabolic equivalents (METs).
Measured: From enrolment to 12 months
Illness perception
Brief Illness Perception Questionnaire (BIPQ) is a nine-item scale that measures the cognitive and emotional representations of illness.
Measured: From enrolment to 12 months
Anxiety and depression
Patient Health Questionnaire-4 (PHQ-4) is a self-reported questionnaire to assess for anxiety and depression over the last 2 weeks. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety.
Measured: From enrolment to 12 months
Productivity loss
The Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) is a generic tool to measure productivity losses.
Measured: From enrolment to 12 months
Fraility
The Rockwood Clinical Frailty Scale (CFS) is a tool to summarize the overall level of fitness or frailty of an older individual.
Measured: From enrolment to 12 months
Serious adverse events
Serious adverse events (SAE) post-enrolment will be assessed using electronic health records without the need for participant contact. The SAE of interest are pre-specified in the protocol. Where e-health records are not an option, then an annual contact with the participant should be undertaken to assess for SAE. The final visit is defined as when the last participant has completed 12 months follow-up. The minimum duration of follow-up will be 12 months and the maximum duration of follow-up is anticipated to be up to 48 months. Longer term follow-up to 20 years will be undertaken using electronic health record linkage.
Measured: From enrolment to 12 months
Low density lipoprotein
Abnormal lipid metabolism, and hyperlipidemia, mediate atherogenesis. The circulating concentrations of low density lipoprotein, a proatherogenic lipid, will be assessed.
Measured: From enrolment to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start17 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
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 Angina (Stable)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- NHS National Waiting Times Centre Board
- Sponsor type
- University, hospital or other
- Collaborators
- Robertson Centre for Biostatistics - University of Glasgow, British Heart Foundation, Abbott Medical Devices, CoreAalst BV, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Colin Berry, NHS National Waiting Times Centre Board
- Investigators
- Colin Berry, BSc MBChB PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854302
- Sponsor's protocol ID
- 24/CARD/08
- Acronym
- CorMicA-PCI
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with bone fide research collaborators upon reasonable request with the agreement of the sponsor and chief investigator
Publications
Crea F, Bairey Merz CN, Beltrame JF, Berry C, Camici PG, Kaski JC, Ong P, Pepine CJ, Sechtem U, Shimokawa H. Mechanisms and diagnostic evaluation of persistent or recurrent angina following percutaneous coronary revascularization. Eur Heart J. 2019 Aug 1;40(29):2455-2462. doi: 10.1093/eurheartj/ehy857.
PubMed 30608528
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angina After PCI: a Systems Medicine Cohort Study
- ClinicalTrials.gov ID
- NCT06854302
- Acronym / sponsor ID
- CorMicA-PCI / 24/CARD/08
- Conditions
- Angina (Stable), Ischemic Heart Disease (IHD)
- Keywords
- Angina, Microvascular angina, Percutaneous coronary intervention, Systems medicine, Health economics, cohort study, coronary artery disease, Cardiovascular magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- NHS National Waiting Times Centre BoardUniversity, hospital or other
- Collaborators
- Robertson Centre for Biostatistics - University of Glasgow, British Heart Foundation, Abbott Medical Devices, CoreAalst BV, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 3 Mar 2025 (actual)
- 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.
Angina may persist or recur in patients treated by coronary angioplasty. The angioplasty involves a balloon treatment to open a blocked heart blood vessel and usually a stent (thin metal tube) is placed. Stents do not always improve symptoms and may make symptoms worse. Sometimes a drug-eluting-balloon is used instead of a stent.
This balloon coats the inside of the blood vessel to prevent re-narrowing. Research is needed to clarify the causes of ongoing angina and its impact on patients and the NHS, and to identify which patients will or will not benefit from a stent (hence avoiding over-treatment in the future).
We plan a 5-year UK-wide multicenter study involving up to 600 patients with angina undergoing coronary angioplasty (with or without a stent). They will initially have a heart MRI scan. We will assess what might influence the recurrence of angina in the year after the angioplasty procedure. We will measure small blood vessel function in the heart and the amount of plaque persisting after PCI.
Patients who report angina after coronary angioplasty usually have a second invasive angiogram. Instead, we will invite patients to have a heart MRI scan allowing us to also assess whether this scan might be more useful than a repeat angiogram in guiding clinical care. We will collaborate with life scientists, mathematicians, statisticians, and health economists to better understand causes and health economic implications of angina arising after coronary angioplasty procedures.
Detailed description
Background: Prior studies indicate that potentially one in three patients may experience angina within 12 months of undergoing percutaneous coronary intervention (PCI).
Hypothesis: 1) Diffuse coronary atherosclerosis and/or microvascular dysfunction impair myocardial blood flow (MBF) leading to angina post-PCI.
Design: A 5-year interdisciplinary program with 3 scientific work-packages (WPs): 1) Clinical, 2) Systems medicine, and 3) Health Economics.
WP1) Cohort study In 4 or more centers in the United Kingdom, 600 patients with angina will undergo stress/rest perfusion cardiovascular magnetic resonance (CMR) imaging with inline pixel-mapping of MBF (ml/min/g) and then coronary physiology measured during PCI. Patient reported outcome measures will be collected routinely during follow-up to 12 months.
Primary outcome: Adjudicated, residual angina (Seattle Angina Questionnaire Angina Frequency (SAQ-7-AF) score <90).
Nested case-control study: stress perfusion CMR (MBF culprit artery territory, primary outcome) in approximately 200 patients reporting residual angina and 50 consecutive asymptomatic controls (all post-PCI). Clinically indicated coronary angiography including physiology tests (change from baseline measurement) and acetylcholine testing will be undertaken in approximately 120 patients.
WP2) Systems medicine (n=600) using biostatistics to identify multivariable baseline associates (clinical, coronary physiology, haemodynamics, circulating biomarkers (DNA, RNA, protein) of the SAQ-7-AF score (range 0 (Severe) - 100 (no angina)) post-PCI.
WP3) Health economics of NHS resource utilization and value of information (VoI) modelling to design stratified medicine trials.
Value: Identification of mechanisms to inform downstream diagnostic and therapeutic strategies for angina post-PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving percutaneous coronary intervention | – | Diagnostic Test: Cardiovascular magnetic resonance imaging, Diagnostic Test: Coronary physiologyThe study population will include individuals with stable angina who undergo stress perfusion cardiovascular magnetic resonance (CMR) imaging before invasive management. Eligibility will be sequentially assessed. Informed consent will initially be based on angina occurring in patients in whom there is a reasonable expectation for invasive management. Stress CMR imaging should be undertaken on either clinical grounds or for research. Potentially, 700 patients will provide written informed consent. Finally, eligibility will be reassessed during invasive management and eligibility will be confirmed when percutaneous coronary intervention is completed. The population will be defined by individuals who fulfil the eligibility criteria. The target sample size is 600 patients with complete data post-PCI. This sample size is anticipated to lead to approximately 200 participants who will report angina consistent with an Seattle Angina Questionnaire Angina Frequency score <90. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable angina in whom stress perfusion CMR imaging is reasonable on clinical and/or research grounds and in whom invasive management is plausible or intended will be eligible to participate.
Key inclusion criteria (6 listed)
- BEFORE INVASIVE MANGEMENT
- Angina by SAQ-7 Angina Frequency Score <90*
- Stress CMR imaging*
- DURING INVASIVE MANAGEMENT
- PCI (successful)
Key exclusion criteria (6 listed)
- Age <=18 years
- Acute MI within 30 days
- Invasive management >90 days after stress CMR
- Inability to comply with the protocol
- Lack of written informed consent.
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 |
|---|---|---|
| Cardiovascular magnetic resonance imagingObservational diagnostic tests will include adenosine-stress perfusion cardiovascular magnetic resonance imaging before undergoing percutaneous coronary intervention. | Diagnostic test | Patients receiving percutaneous coronary intervention |
| Coronary physiologyInvasive coronary function tests using a diagnostic guidewire (PressureWire-X, Abbott), thermodilution, intravenous or intracoronary infusion of adenosine and intracoronary infusions of acetylcholine. | Diagnostic test | Patients receiving percutaneous coronary intervention |
Primary outcome
Residual angina after percutaneous coronary intervention.
Time frame: From enrolment to 12 months
Residual angina post-PCI, defined as adjudicated, angina (Seattle Angina Questionnaire Angina Frequency (SAQ-7-AF) score <90) occurring within one year of percutaneous coronary intervention.
14 secondary outcomes
Angina
Time frame: From enrolment to 12 months
Myocardial perfusion reserve
Time frame: From enrolment to 12 months
Fractional flow reserve post-percutaneous coronary intervention
Time frame: 24 hours
Coronary flow reserve after percutaneous coronary intervention
Time frame: 24 hours
Index of microvascular resistance after percutaneous coronary intervention
Time frame: 24 hours
Microvascular dysfunction after percutaneous coronary intervention
Time frame: 24 hours
Health-related quality of life
Time frame: From enrolment to 12 months
Physical function
Time frame: From enrolment to 12 months
Illness perception
Time frame: From enrolment to 12 months
Anxiety and depression
Time frame: From enrolment to 12 months
Productivity loss
Time frame: From enrolment to 12 months
Fraility
Time frame: From enrolment to 12 months
Serious adverse events
Time frame: From enrolment to 12 months
Low density lipoprotein
Time frame: From enrolment to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Background: PubMed 30608528Crea F, Bairey Merz CN, Beltrame JF, Berry C, Camici PG, Kaski JC, Ong P, Pepine CJ, Sechtem U, Shimokawa H. Mechanisms and diagnostic evaluation of persistent or recurrent angina following percutaneous coronary revascularization. Eur Heart J. 2019 Aug 1;40(29):2455-2462. doi: 10.1093/eurheartj/ehy857.
- Individual participant dataSharing planned: Yes. IPD will be shared with bone fide research collaborators upon reasonable request with the agreement of the sponsor and chief investigator
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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.
Colin Berry, BSc MBChB PhD principal investigator
University of Glasgow
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina (Stable) and Ischemic Heart Disease (IHD), run by NHS National Waiting Times Centre Board at 4 sites 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 6 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: enrolling by invitation, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Residual angina after percutaneous coronary intervention. (time frame: From enrolment to 12 months). 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 NCT06854302, 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 3 Mar 2025.