Coronary AngiographyEarly Phase 1NCT00960817
"Normal Coronary Artery" With Slow Flow Improved by Adenosine Injection, Dipyridamole Treatment and Clinical Follow-up
A Early Phase 1 study testing Statin, aspirin and Dipyridamole in people with Coronary Angiography, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The investigators will investigate patients undergoing coronary angiography with normal coronary but slow blood flow that was normalized after adenosine injection into the coronary artery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Angiography
- What is being tested?
- Statin, aspirin and Dipyridamole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Early Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing coronary angiography and who have normal coronary artery with slow blood flow that normalized with adenosine injection into the coronary artery
Who cannot join
- Significant coronary disease
- Unstable patients
- Patients with known sensitivity to dipyridamole
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will investigate patients undergoing coronary angiography with normal coronary but slow blood flow that was normalized after adenosine injection into the coronary artery. The investigators believe that they have small vessel coronary disease which is the initial presentation of coronary disease prior to anatomical narrowing. To alleviate this phenomenon the investigators intend to examine the long-term clinical response of these patients to treatment with dipyridamole, a well-known medication with almost no side-effects that increases the level of adenosine in the tissue.
- Conditions
- Coronary Angiography
- Being tested
- Statin, aspirin, Dipyridamole
- Keywords
- Normal coronary artery with slow blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statin, aspirinDrug
DipyridamoleDrug
| Study group | Role | What they receive |
|---|---|---|
| 1. Routine treatment | Active comparator | Control group Receives: Drug: Statin, aspirin |
| 2. Dipyridamole treatment | Experimental | Group that receives Dipyridamole treatment Receives: Drug: Dipyridamole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alleviation of chest pain
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960817
- Sponsor's protocol ID
- HYMC 02/2009
- Status last verified
- Aug 2009
- First submitted
- 17 Aug 2009
- Last updated
- 18 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Normal Coronary Artery" With Slow Flow Improved by Adenosine Injection, Dipyridamole Treatment and Clinical Follow-up
- ClinicalTrials.gov ID
- NCT00960817
- Acronym / sponsor ID
- HYMC 02/2009
- Conditions
- Coronary Angiography
- Keywords
- Normal coronary artery with slow blood flow
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- First posted
- 18 Aug 2009 (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 investigators will investigate patients undergoing coronary angiography with normal coronary but slow blood flow that was normalized after adenosine injection into the coronary artery. The investigators believe that they have small vessel coronary disease which is the initial presentation of coronary disease prior to anatomical narrowing. To alleviate this phenomenon the investigators intend to examine the long-term clinical response of these patients to treatment with dipyridamole, a well-known medication with almost no side-effects that increases the level of adenosine in the tissue.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Routine treatment | Active comparator | Drug: Statin, aspirinControl group |
| 2. Dipyridamole treatment | Experimental | Drug: DipyridamoleGroup that receives Dipyridamole treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing coronary angiography and who have normal coronary artery with slow blood flow that normalized with adenosine injection into the coronary artery
Key exclusion criteria (3 listed)
- Significant coronary disease
- Unstable patients
- Patients with known sensitivity to dipyridamole
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 |
|---|---|---|
| Statin, aspirin | Drug | 1. Routine treatment |
| Dipyridamole | Drug | 2. Dipyridamole treatment |
Primary outcome
Alleviation of chest pain
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Statin, aspirin and Dipyridamole in people with Coronary Angiography, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 3 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 18 Aug 2009. 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 Israel. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Alleviation of chest pain (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2009; AzTrials last refreshed its copy on 31 Oct 2026.