Angina PectorisPhase 4NCT01582165
Women With Chest Pain and no Significant Coronary Artery Stenosis; A Study on Microvascular Resistance
A Phase 4 study testing Rosuvastatin in people with Angina Pectoris, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Female patients presenting with persistent chest pain despite no obstructive coronary artery disease have impaired prognosis. Stress tests are often positive or inconclusive. As much as 20% of women with chest pain and minimal angiographic CAD have evidence of myocardial ischemia, suggesting impaired coronary… Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2012to Jun 2016
- Phase
- Phase 4
- 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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female gender
- Age 30 - 70 years
- Chest pain suggestive of symptomatic coronary artery disease
- A coronary angiogram with no or minimal coronary artery disease
- Fractional flow reserve value over 0,80
Who cannot join
- Male gender
- Age under 30 years or over 70
- Coronary artery stenosis ≥ 33 % in any epicardial vessel
- Fractional flow reserve value ≤ 0,80
- Pregnant or nursing women
- Women of childbearing potential not using contraception
Show all 12Show fewer
- Short life expectancy
- Uncontrolled endocrinological disease
- Arterial hypertension
- Structural heart disease
- Significant mental disorder, including dementia
- Inability to comply with the protocol -
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, Dep of Cardiology, Rikshospitalet
Oslo, Oslo, 0380
About this study
Official title: Microvascular Resistance in Women With Chest Pain and no or Minimal Coronary Artery Disease
Female patients presenting with persistent chest pain despite no obstructive coronary artery disease have impaired prognosis. Stress tests are often positive or inconclusive. As much as 20% of women with chest pain and minimal angiographic CAD have evidence of myocardial ischemia, suggesting impaired coronary microcirculation. The index of microvascular resistance (IMR) is a method for indirectly investigating microvascular function in the cardiac catheterization laboratory.
66 female patients, age 30-70 years, with chest pain and "normal" or near normal coronary angiograms will be included. After coronary physiologic evaluation, patients will be randomized in a double blind study to rosuvastatin 20 mg/day or matching placebo tablets for altogether 6 months.
Read more
The investigators hypothesize that:
- A substantial number of women with chest pain and normal or minimal pathology on angiograms have microvascular dysfunction defined by a raised IMR.
- Statins, based on its pleiotropic action will improve endothelial function and thereby IMR.
- Conditions
- Angina Pectoris
- Being tested
- Rosuvastatin, Placebo.
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Rosuvastatin 20 mg once daily vs placebo for 6 months
Placebo.Drug
Placebo once daily vs rosuvastatin for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Angina. IMR. Statin. | Active comparator | Not described Receives: Drug: Rosuvastatin |
| Angina. IMR. Placebo. | Placebo comparator | Not described Receives: Drug: Placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal changes in microvascular perfusion indices (Index of Microvascular Function (IMR) and Coronary Flow Reserve (CFR)).
During a left heart catheterization IMR and CFR are measured at baseline and at 6 months. Patients are randomized to rosuvastatin vs placebo. The objectives are to determine whether women with chest pain with no or minimal angiographic coronary artery disease, have a raised index of microvascular resistance and to determine whether high-dose statin treatment will modify microvascular perfusion indices in these patients.
Measured: 6 months
Secondary outcomes (1)
Angina pectoris classification (CCS).
Women with chest pain are randomized to rosuvastatin vs placebo. Angina pectoris (CCS classification) will be compared in the two arms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2016
- Study completionJun 2016
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 PectorisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole Geir Solberg, Oslo University Hospital
- Investigators
- Lars Aaberge, MD, PhD, Principal investigator, Oslo University Hospital Rikshospitalet, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582165
- Sponsor's protocol ID
- 3tcAZ
- Other IDs
- 2011-002630-39
- Status last verified
- Sep 2016
- First submitted
- 16 Apr 2012
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Analyses of the study will start within a few weeks or months. Publication planned in 2017
Publications
Solberg OG, Stavem K, Ragnarsson A, Beitnes JO, Skardal R, Seljeflot I, Ueland T, Aukrust P, Gullestad L, Aaberge L. Index of microvascular resistance to assess the effect of rosuvastatin on microvascular function in women with chest pain and no obstructive coronary artery disease: A double-blind randomized study. Catheter Cardiovasc Interv. 2019 Nov 1;94(5):660-668. doi: 10.1002/ccd.28157. Epub 2019 Feb 21.
PubMed 30790446
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Resistance in Women With Chest Pain and no or Minimal Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01582165
- Acronym / sponsor ID
- 3tcAZ
- Conditions
- Angina Pectoris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Apr 2012 (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.
Female patients presenting with persistent chest pain despite no obstructive coronary artery disease have impaired prognosis. Stress tests are often positive or inconclusive. As much as 20% of women with chest pain and minimal angiographic CAD have evidence of myocardial ischemia, suggesting impaired coronary microcirculation. The index of microvascular resistance (IMR) is a method for indirectly investigating microvascular function in the cardiac catheterization laboratory.
66 female patients, age 30-70 years, with chest pain and "normal" or near normal coronary angiograms will be included. After coronary physiologic evaluation, patients will be randomized in a double blind study to rosuvastatin 20 mg/day or matching placebo tablets for altogether 6 months.
The investigators hypothesize that:
- A substantial number of women with chest pain and normal or minimal pathology on angiograms have microvascular dysfunction defined by a raised IMR.
- Statins, based on its pleiotropic action will improve endothelial function and thereby IMR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angina. IMR. Statin. | Active comparator | Drug: Rosuvastatin |
| Angina. IMR. Placebo. | Placebo comparator | Drug: Placebo. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female gender
- Age 30 - 70 years
- Chest pain suggestive of symptomatic coronary artery disease
- A coronary angiogram with no or minimal coronary artery disease
- Fractional flow reserve value over 0,80
Key exclusion criteria (12 listed)
- Male gender
- Age under 30 years or over 70
- Coronary artery stenosis ≥ 33 % in any epicardial vessel
- Fractional flow reserve value ≤ 0,80
- Pregnant or nursing women
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 |
|---|---|---|
| RosuvastatinRosuvastatin 20 mg once daily vs placebo for 6 months | Drug | Angina. IMR. Statin. |
| Placebo.Placebo once daily vs rosuvastatin for 6 months | Drug | Angina. IMR. Placebo. |
Primary outcome
Temporal changes in microvascular perfusion indices (Index of Microvascular Function (IMR) and Coronary Flow Reserve (CFR)).
Time frame: 6 months
During a left heart catheterization IMR and CFR are measured at baseline and at 6 months. Patients are randomized to rosuvastatin vs placebo. The objectives are to determine whether women with chest pain with no or minimal angiographic coronary artery disease, have a raised index of microvascular resistance and to determine whether high-dose statin treatment will modify microvascular perfusion indices in these patients.
1 secondary outcome
Angina pectoris classification (CCS).
Time frame: 6 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 27 Sep 2016.
- Derived from this study: PubMed 30790446Solberg OG, Stavem K, Ragnarsson A, Beitnes JO, Skardal R, Seljeflot I, Ueland T, Aukrust P, Gullestad L, Aaberge L. Index of microvascular resistance to assess the effect of rosuvastatin on microvascular function in women with chest pain and no obstructive coronary artery disease: A double-blind randomized study. Catheter Cardiovasc Interv. 2019 Nov 1;94(5):660-668. doi: 10.1002/ccd.28157. Epub 2019 Feb 21.
- Individual participant dataSharing planned: Undecided. Analyses of the study will start within a few weeks or months. Publication planned in 2017
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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.
Lars Aaberge, MD, PhD principal investigator
Oslo University Hospital Rikshospitalet, Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin in people with Angina Pectoris, run by Oslo University Hospital at 1 site in Norway.
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 5 inclusion and 12 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 27 Sep 2016. 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 Norway. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Temporal changes in microvascular perfusion indices (Index of Microvascular Function (IMR) and Coronary Flow Reserve (CFR)). (time frame: 6 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 NCT01582165, 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 27 Sep 2016.